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Drug Study, March 21, 2012

Canada

Drug Class: Antidepressant,

Generic Name: Citalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Amitriptyline, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Trimipramine, Venlafaxine, Norpramin, Pertofrane,

Brand Name: Celexa, Prozac, Luvox, Zoloft, Elavil, Endep, Vanatrip, Anafranil, Adapin, Silenor, Sinequan, Tofranil, Aventyl, Pamelor, Surmontil, Effexor,

Age: Adults (18 and over), Children (under 18)

Side Effects: High Blood Pressure,

Summary: British Journal of Clinical Pharmacology published a study where the authors reviewed 1,216 women with pregnancy-induced hypertension (high blood pressure) and no history of hypertension. When compared to a control group, women using Antidepressants (including SSRI's, trycyclic Antidepressants, and SNRIs) during pregnancy were at increased risk of pregnancy-induced hypertension, especially those on SSRIs.

Source: Mary A De Vera Ph, Anick Berard PhD, FISPE, "Antidepressant Use During Pregnancy and the Risk of Pregnancy Induced Hypertension," British Journal of Clinical Pharmacology, 21 Mar 2012.

 

Drug Study, January 18, 2012

Netherlands

Drug Class: Antidepressant, Antianxiety,

Generic Name: Citalopram, Paroxetine, Sertraline, Fluvoxamine, Amitriptyline, Nortriptyline, Trazodone, Mirtazapine,

Brand Name: Celexa, Paxil, Seroxat, Zoloft, Luvox, Elavil, Endep, Vanatrip, Aventyl, Pamelor, Desyrel, Oleptro, Remeron,

Age: Adults (18 and over)

Side Effects: Falls,

Summary: The British Journal of Psychiatry published a study that found daily drug use and daily falls were recorded in 248 nursing home residents with dementia from 2006 until 2008. Even at low doses, SSRIs were associated with increased risk of an injurious fall in nursing home residents with dementia and the use of a SSRI in combination with a hypnotic or sedative further increased the risk.

Source: Carolyn S. Sterke MSc, Gijsbertus Ziere MD, PhD, Ed F. van Beeck MD, PhD, Caspar W. N. Looman MSc, Tischa J. M. van der Cammen MD, PhD, "Dose-response relationship between Selective Serotonin Reuptake Inhibitors and Injurious Falls: A study in Nursing

 

Drug Study, January 12, 2012

Nordic Countries

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Citalopram, Paroxetine, Sertraline, Fluvoxamine, Escitalopram,

Brand Name: Prozac, Celexa, Paxil, Seroxat, Zoloft, Luvox, Lexapro,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: A study published in the British Medical Journal looked at 1.6 million infants born between 1996-2007. The authors found that mothers who used SSRIs late in pregnancy increased the risk of their child being born with a birth defect effecting breathing, know as persistent pulmonary hypertension. This increased risk was more than two folds.

Source: Helle Kieler, Miia Artama, Anders Engeland, Orjan Ericsson, Kari Furu, Mika Gissler, Rikke Beck Nielsen, Mette Norgaard, Olof Stephansson, Unnur Valdimarsdottir, Helga Zoega, Bengt Haglund, "Selective serotonin reuptake inhibitors during pregnancy and

 

Drug Study, December 19, 2011

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Obesity,

Summary: A study was published in the Journal of Clinical Oncology that looked at the obesity rates of 9,284 adult who had a diagnoses of cancer between the ages of 5 to 9. They found that one of the factors contributing to the obesity rates are certain Antidepressant drugs taken.

Source: Daniel M. Green, Cheryl L. Cox, Liang Zhu, Kevin R. Krull, Deo Kumar Srivastava, Marilyn Stovall, Vikki G. Nolan, Kirsten K. Ness, Sarah S. Donaldson, Kevin C. Oeffinger, Lillian R. Meacham, Charles A. Sklar, Gregory T. Armstrong and Leslie L. Robison, "

 

Drug Warning, December 14, 2011

United States

Drug Class: Antidepressant,

Generic Name: Vilazodone, Sertraline, Paroxetine, Fluvoxamine, Fluoxetine, Escitalopram, Citalopram,

Brand Name: Celexa , Lexapro, Prozac, Sarafem, Symbyax, Luvox, Luvox CR, Paxil, Paxil CR, Seroxat, Pexeva, Zoloft, Viibryd,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: The FDA notified healthcare professionals and the public about the use of selective serotonin reuptake inhibitor (SSRI) Antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN - a heart and lung problem).

Source: "Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn" FDA, December 14, 2011, http://www.fda.gov/Safety/MedWatch/SafetyIn

 

Drug Warning, December 01, 2011

United Kingdom

Drug Class: Antidepressant,

Generic Name: Citalopram, Escitalopram,

Brand Name: Celexa, Lexapro,

Age: Adults (18 and over)

Side Effects: Heart Problems,

Summary: A warning issued by the Medicines Healthcare products Regulatory Agency (MHRA) alerting that use of citalopram and escitalopram with drugs that prolong QT intervals (heart beat irregularity) may have an additive effect.

Source: "Citalopram and escitalopram: QT interval prolongation-new maximum daily dose restrictions (including in elderly patients), contraindications, and warnings" MHRA, December 2011, www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON137769

 

Drug Warning, December 01, 2011

United States

Drug Class: Antidepressant,

Generic Name: Mirtazapine,

Brand Name: Remeron,

Age: Adults (18 and over)

Side Effects: Neuroleptic Malignant Syndrome,

Summary: The Food and Drug Administration updated Remeron's label to include the warning that development of potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)* like reactions have been reported with SSRIs, SNRIs, MAOIs, and other drugs including Remeron. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic (part of the nervous system) instability (e.g., rapid heart beat, often changing blood pressure, abnormally high fever), neuromuscular aberrations (e.g., exaggerated reflexes, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). *Neuroleptic Malignant Syndrome: a life-threatening neurological disorder most often caused by an adverse reaction to antipsychotic drugs. High fever, sweating, rigidity, blood pressure changes, confusion, coma, and sometimes death are caused.

Source: Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating tablets. MedWatch Safety Information, December 2011, http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm287583.htm

 

Drug Study, December 01, 2011

United States

Drug Class: Antidepressant,

Generic Name: Venlafaxine, Sertraline,

Brand Name: Effexor, Zoloft,

Age: Adults (18 and over)

Side Effects: Lack of Efficacy,

Summary: The Journal of Clinical Psychiatry published a study where researchers conducted a trial from Nov 2001 to June 2007, with 156 patients diagnosed with Major Depressive Disorder. The patients were treated for 16 weeks with either psychotherapy, sertraline (and if that failed, they were switched to venlafaxine), or a placebo. The authors concluded that this trial showed that both active treatments failed to be better than placebo.

Source: Jacques P. Barber, PhD; Marna S. Barrett, PhD; Robert Gallop, PhD; Moira A. Rynn, MD; and Karl Rickels, MD, "Short-Term Dynamic Psychotherapy Versus Pharmacotherapy for Major Depressive Disorder: A Randomized, Placebo-Controlled Trial," Journal of Clin

 

Drug Study, November 26, 2011

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Diabetes,

Summary: The European Journal of Clinical Pharmacology published a study based on the Texas Medicaid prescription claims database, where the researchers looked at 44,715 people, and compared those who had been exposed to Antidepressants to those who hadn't been exposed. They found that Antidepressant use was associated with an increased risk of diabetes. The association was observed with all the types of Antidepressants they looked at.

Source: S. Khoza, J. C. Barner, T. M. Bohman, K. Rascati, K. Lawson and J. P. Wilson, "Use of Antidepressant agents and the risk of type 2 diabetes," European Journal of Clinical Pharmacology, 26 Nov. 2011

 

Drug Warning, November 01, 2011

Australia

Drug Class: Antidepressant,

Generic Name: Atomoxetine,

Brand Name: Strattera,

Age: Adults (18 and over), Children (under 18)

Side Effects: High Blood Pressure, Heart Problems,

Summary: The Therapeutics Goods Administration (TGA) advised health professionals and patients of important safety information regarding the risk of increased blood pressure and/or heart rate with the use of atomoxetine. These effects could represent a risk for some patients.

Source: "Atomoxetine (STRATTERA) - risk of increased blood pressure and/or heart rate" TGA, November 2011, http://www.tga.gov.au/safety/alerts-medicine-atomoxetine-111102.htm

 

Drug Study, November 01, 2011

United Kingdom

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Falls,

Summary: A study in Drugs & Aging reported that Antidepressant medications have long been related to the cause of falls in older people, but these researchers specifically looked at the risk associated to serotonin-norepinephrine (noradrenaline) reuptake inhibitors (SNRIs) type Antidepressants. In looking at 9,862 individuals over 60, the authors compared the rate of falls during treatment with SNRIs to those not taking SNRIs. Based on their review, the authors concluded that the SNRI treatment is associated with the risk of falls.

Source: Gribbin, Jonathan; Hubbard, Richard; Gladman, John; Smith, Chris; Lewis, Sarah, "Serotonin-Norepinephrine Reuptake Inhibitor Antidepressants and the Risk of Falls in Older People: Case-Control and Case-Series Analysis of a Large UK Primary Care Databas

 

Drug Warning, October 01, 2011

United States

Drug Class: Antipsychotic and Antidepressant,

Generic Name: Fluoxetine and Olanzapine,

Brand Name: Symbyax,

Age: Adults (18 and over)

Side Effects: Sexual Dysfunction,

Summary: The Food and Drug Administration updated Symbyax's label to include additional adverse reactions for sexual dysfunction, which can persist even after discontinuation.

Source: Symbyax (olanzapine and fluoxetine HCl), MedWatch Safety Information, October 2011, http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm279262.htm

 

Drug Warning, September 01, 2011

United States

Drug Class: Antidepressant,

Generic Name: Duloxetine,

Brand Name: Cymbalta,

Age: Adults (18 and over)

Side Effects: Skin Problems, Skin Reactions,

Summary: The Food and Drug Administration (FDA) updated Cymbalta's label to warn that severe skin reactions including erythema multiforme (Stevens-Johnson Syndrome - rash and blisters) can occur with Cymbalta.

Source: Cymbalta (duloxetine hydrochloride), MedWatch Safety Information, September 2011, http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm255064.htm

 

Drug Study, September 01, 2011

Australia

Drug Class: Mood Stabilizer, Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Car Accidents,

Summary: A study was published in the Journal of the American Geriatrics Society where the researchers reviewed 616 individuals aged 60 and older who were hospitalized as the result of a motor vehicle crash between 2002 and 2008 in Western Australia. They found that there was a greater risk of a crash requiring hospitalization in older drivers prescribed benzodiazepines and Antidepressants.

Source: Lynn B. Meuleners PhD, Janine Duke PhD, Andy H. Lee PhD, Peter Palamara MSc, Janina Hildebrand BSc, Jonathon Q. Ng MD, "Psychoactive Medications and Crash Involvement Requiring Hospitalization for Older Drivers: A Population-Based Study," Journal of th

 

Drug Warning, August 24, 2011

United States

Drug Class: Antidepressant,

Generic Name: Citalopram,

Brand Name: Celexa,

Age: Adults (18 and over)

Side Effects: Heart Problems,

Summary: The FDA issued a warning to doctors about prescribing the Antidepressant Celexa (citalopram hydrobromide) above certain dosages as it can cause abnormal changes in the electrical activity of the heart. The safety announcement said that Celexa "should no longer be used at doses greater than 40 mg per day."

Source: "FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide)," FDA, 24 August 2011, http://www.fda.gov/Drugs/DrugSafety/ucm269086.htm.

 

Drug Study, August 02, 2011

United Kingdom

Drug Class: Antidepressant,

Generic Name: Fluoxetine , Amitriptyline , Dosulepin , Venlafaxine , Sertraline , Mirtazapine, Lofepramine, Escitalopram, Trazodone, Citalopram,

Brand Name: Prozac, Elavil, Endep, Vanatrip, Prothiaden, Dothep, Thaden, Dopress, Effexor, Zoloft, Remeron, Gamanil, Tymelyt, Lomont, Lexapro, Desyrel, Oleptro,

Age: Adults (18 and over)

Side Effects: Death, Suicide, Falls, Fractures, Gastrointestinal Problems, Suicide Attempts,

Summary: The British Medical Journal published a study where the authors assessed the risk of several side effects of Antidepressants in the elderly, and how these risks are affected by length of use and dosage. They took data from over 54,000 UK patients who have received at least one prescription of an Antidepressant. They found that, "All classes of Antidepressant drug were associated with significantly increased risks of mortality, attempted suicide/self harm, falls, fractures, and upper gastrointestinal bleeding compared with when these drugs were not being used." And surprisingly, SSRIs, compared to older (tricyclic) Antidepressants, had higher rates of many of the previously mentioned risks.

Source: Carol Coupland, Paula Dhiman, Richard Morriss, Antony Arthur, Garry Barton, Julia Hippisley-Cox, "Antidepressant use and risk of adverse outcomes in older people: population based cohort study," British Medical Journal, Vol. 343, 2 Aug. 2011.

 

Drug Warning, August 01, 2011

Australia

Drug Class: Antidepressant,

Generic Name: Venlafaxine,

Brand Name: Effexor,

Age: Adults (18 and over)

Side Effects: Heart Problems,

Summary: The Therapeutic Goods Administration, in their Medicines Safety Update, said that stress cardiomyopathy (deterioration of the heart muscle) may be an adverse effect of venlafaxine (Antidepressant also known as Effexor).

Source: "Venlafaxine and Stress Cardiomyopathy," Medicines Safety Update, Vol. 2, No. 4, Aug 2011.

 

Drug Warning, July 26, 2011

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine, Fluvoxamine, Fluoxetine, Sertraline, Citalopram, Escitalopram, Venlafaxine, Desvenlafaxine, Duloxetine, Amitriptyline, Desipramine, Clomipramine, Imipramine, Nortriptyline, Protriptyline, Doxepin, Trimipramine, Isocarboxazid, Phenelzine, Selegiline, Tranylcypromine, Amoxapine, Maprotiline, Nefazodone, Trazodone, Bupropion, Buspirone, Vilazodone, Mirtazapine,

Brand Name: Paxil, Seroxat, Pexeva, Luvox, Prozac, Sarafem, Symbyax, Zoloft, Celexa, Lexapro, Effexor, Pristiq, Cymbalta, Amitid, Amitril, Elavil, Endep, Etrafon, Limbitrol, Triavil, Norpramin, Pertofrane, Anafranil, Tofranil, Janimine, Pramine, Presamine, Pamelor, Aventyl, Vivactil, Sinequan, Zonalon, Silenor, Surmontil, Marplan, Nardil, Emsam, Eldepryl, Zelapar, Parnate, Asendin, Ludiomil, Serzone, Desyrel, Oleptro, Trialodine, Wellbutrin, Zyban, Aplenzin, Buspar, Viibryd, Remeron, Norpramin, Pertofrane,

Age: Adults (18 and over)

Side Effects: Nervous System Disorders,

Summary: The FDA issued a warning about serious central nervous system (CNS) reactions that occur when the antibacterial drug linezolid (Zyvox) is given to patients taking psychiatric medications that work through the serotonin system of the brain. Some of the reactions included Serotonin Syndrome a potentially (a life threatening drug reaction that causes the body to have too much serotonin), trouble with coordination, muscle twitching, etc. There were also some deaths reported.

Source: Zyvox (linexolid), MedWatch Safety Information, July 26, 2011.

 

Drug Study, July 18, 2011

United Kingdom

Drug Class: Antidepressant,

Generic Name: Sertraline, Mirtazapine,

Brand Name: Zoloft, Remeron,

Age: Adults (18 and over)

Side Effects: Lack of Efficacy,

Summary: The Lancet published a study where the authors took the two most commonly prescirbed drugs for depression, sertraline and mirtazapine, and compared it with placebo in a double-blind (both the doctor and the patient don't know which drug is real, and which is placebo) study. In treating depression in dementia patients for 39 weeks, the authors did not find any benefit of using these drugs over placebo, and recommend use of these Antidepressants be reconsidered. "Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these Antidepressants, with usual care, for first-line treatment of depression in Alzheimer's disease should be reconsidered."

Source: Sube Banerjee, et al, "Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial" The Lancet, Vol. 378, p 403-411, 30 Jul 2011.

 

Drug Study, July 04, 2011

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over), Children (under 18)

Side Effects: Autism,

Summary: The Archives of General Psychiatry published a study where researchers took data from 20 autistic children who had prenatal exposure to Antidepressant medications and 50 randomly selected autistic children. The researchers found a 2-fold increased risk of autism associated with a mother using SSRI Antidepressants during the year before delivery. The risk was greater when the mothers used SSRIs in their first trimester. The authors concluded that, though this was a small study, exposure to SSRIs caused a small increased risk of autism. The study also said, "No increase in risk was found for mothers with a history of mental health treatment in the absence of prenatal exposure to selective serotonin reuptake inhibitors."

Source: Lisa A. Croen, PhD; Judith K. Grether, PhD; Cathleen K. Yoshida, MS; Roxana Odouli, MSPH; Victoria Hendrick, MD, "Antidepressant Use During Pregnancy and Childhood Autism Spectrum Disorders," Archives of General Psychiatry, published online July 4, 201

 

Drug Study, July 01, 2011

Finland

Drug Class: Antidepressant,

Generic Name: Citalopram, Fluoxetine, Paroxetine, Sertraline, Escitalopram, Fluvoxamine,

Brand Name: Celexa, Prozac, Paxil, Seroxat, Zoloft, Lexapro, Luvox,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: The journal Obstetrics & Gynecology published a Finnish population-based study of 635,583 births, where 6,976 (1.1%) of the fetuses were exposed to SSRIs during the first trimester. The authors found "that exposure to fluoxetine (Prozac) and paroxetine (Paxil) in early pregnancy is associated with a small but established risk of specific cardiovascular anomalies [heart defects]..."

Source: Heli Malm, MD, PhD, Miia Artama, MSc, PhD, Mika Gissler, MSocSc, PhD, and Annukka Ritvanen, MD, "Selective Serotonin Reuptake Inhibitors and Risk for Major Congenital Anomalies," Obstetrics & Gynecology, Vol. 118, No. 1, July 2011.

 

Drug Study, June 08, 2011

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Falls,

Summary: The Journal of Gerontology published a study where the authors looked at 1,181 nursing home residence who had fallen, and evaluated the duration and change of their Antidepressant use. They found that "Nursing home residents are at high risk of falls during the days following a new prescription or increased dose of a non-SSRI Antidepressant."

Source: Sarah D. Berry1, Yuqing Zhang, Lewis A. Lipsitz, Murray A. Mittleman, Daniel H. Solomon and Douglas P. Kiel1, "Antidepressant Prescriptions: An Acute Window for Falls in the Nursing Home," The Journals of Gerontology, 8 June 2011.

 

Drug Study, June 07, 2011

France

Drug Class: Antianxiety, Antidepressant,

Generic Name: Alprazolam, Bromazepam,

Brand Name: Niravam, Xanax, Lectopam, Lexotan, Lexilium, Lexaurin, Brazepam, Rekotnil, Bromaze, Lexotanil,

Age: Adults (18 and over)

Side Effects: Aggression, Violence,

Summary: The authors of a study in European Journal of Clinical Pharmacology searched adverse drug reactions recorded in the French PharmacoVigilance Database between 1985 and 2008. They pulled all reports that included the terms aggressiveness or violence and found that "...benzodiazepines and [Antidepressants that affect serotonin] are the main pharmacological classes able to induce aggressive behaviour."

Source: Nadege Rouve, Haleh Bagheri, Norbert Telmon, Atul Pathak, Nicolas Franchitto, Laurent Schmitt, Daniel Rouge, Maryse Lapeyre-Mestre, Jean-Louis Montastruc and the French Association of Regional PharmacoVigilance Centres, "Prescribed drugs and violence:

 

Drug Study, April 06, 2011

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Cancer,

Summary: PLoS One published a study where researchers searched several medical study databases and found 61 articles that assessed the relationship between breast and ovarian cancer and Antidepressant (AD) use and articles that examined the effect of ADs on cell growth. They overall found that, "...short-term use and/or low dose Antidepressants may increase the risk of breast and ovarian cancer, warrants further investigation." In addition, the authors discovered that "Industry affiliations were significantly associated with negative conclusions regarding [AD] cancer risk.

Source: Lisa Cosgrove, Ling Shi, David E. Creasey, Maria Anaya-McKivergan, Jessica A. Myers, Krista F. Huybrechtsm, "Antidepressants and Breast and Ovarian Cancer Risk: A Review of the Literature and Researchers' Financial Associations with Industry," PLoS ONE

 

Drug Study, April 05, 2011

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Heart Problems, Stroke,

Summary: The Emory University School of Medicine carried out a study comparing 59 middle-aged male twins (who both served in the U.S. military during the Vietnam War) where one of the two siblings was treated with an Antidepressant. The researchers found that the brother who used Antidepressants tended to have thicker arteries in the neck, which could contribute to the risk of heart disease and stroke. This study was presented to the American College of Cardiology meeting in New Orleans.

Source: Jennifer Johnson, "Antidepressants Linked to Thicker Arteries," Emory University, 4 Apr. 2011.

 

Drug Warning, April 01, 2011

United States

Drug Class: Antidepressant,

Generic Name: Bupropion,

Brand Name: Aplenzin,

Age: Adults (18 and over)

Side Effects: Agitation, Suicide, Suicide Attempts, Suicide Risk,

Summary: The FDA issued label changes to the Antidepressant Aplenzin. The new label now includes in its adverse reactions and precautions section, agitation and completed suicides.

Source: "Aplenzin (bupropion hydrobromide) Extended-Release Tablets", FDA , April 2011, http://www.fda.gov/Safety/edWatch/SafetyInformation/ucmm254108.htm

 

Drug Warning, April 01, 2011

United States

Drug Class: Antidepressant,

Generic Name: Desvenlafaxine,

Brand Name: Pristiq,

Age: Adults (18 and over)

Side Effects: Nausea, Dizziness, Insomnia, Excessive Sweating, Constipation, Sleepiness, Eating Disorder, Anxiety, High Blood Pressure, Sexual Dysfunction,

Summary: The FDA issued label changes for the Antidepressant Pristiq to include adverse reactions such as nausea, dizziness, insomnia, hyperhidrosis (excessive sweating), constipation, somnolence (sleepy), decreased appetite, anxiety, elevated blood pressure and specific male sexual function disorders.

Source: "Pristiq (desvenllafaxine) extended-release tablets, Detailed View: Safety Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER) - August 2009, December 2010, and April 2011", FDA, April 2011, http://www.fda.gov/Safety/MedWatc

 

Drug Warning, April 01, 2011

United States

Drug Class: Antipsychotic and Antidepressant,

Generic Name: Fluoxetine and Olanzapine,

Brand Name: Symbyax,

Age: Adults (18 and over)

Side Effects: Nervous System Disorders,

Summary: The FDA issued label changes to the drug Symbyaxthat warned that adverse reactions to the nervous system can occur, such as depersonalization, when used with olanzapine or fluoxetine.

Source: "Symbyax (olanzapine and fluoxetine HCL) capsules", FDA, April 2011, http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm254819.htm

 

Drug Warning, April 01, 2011

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects, Heart Problems, Falls, Blood Pressure Changes, Hair Loss Urination Problems, Nervous System Disorders, Teeth Grinding, Bleeding,

Summary: The FDA issued label changes to the Antidepressant Prozac that warned of the potential risk of cardiovascular defects in infants exposed during first trimester. In addition, the following side effects were added to the "Adverse Reaction" section: balance disorder, bruxism (habitual grinding of teeth), gynecological bleeding, hypotension (low blood pressure), alopecia (hair loss), dysuria (painful urination), micturition (urination) disorder and depersonalization.

Source: "Prozac (flluoxetine hydrochloride), Detailed View: Safety Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)" FDA, April 2011, http://www.fda.gov/Safty/MedWatch/SafetyInformation/ucm255402.htm

 

Drug Warning, April 01, 2011

Australia

Drug Class: Antidepressant,

Generic Name: Mirtazapine, Carbamazepine,

Brand Name: Remeron, Carbatrol, Epitol, Equetro, Tegretol,

Age: Adults (18 and over)

Side Effects: Blood Disorders,

Summary: The Australian Therapeutic Goods Administration reported in their Medicines Safety Update bulletin information about drug induced Hyponatraemia (low sodium levels). Frequently reported symptoms of hyponatraemia were confusion, dizziness, dehydration, nausea and vomiting. This side effect was commonly associated with four types of drugs, including Antidepressants.

Source: "Drug-induced hyponatraemia," Medicines Safety Update, Volume 2, Number 2, April 2011.

 

Drug Study, March 28, 2011

Canada

Drug Class: Antipsychotic, Antidepressant, Antianxiety,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Death, Sudden Death, Risk of Fractures,

Summary: The Canadian Medical Association Journal published a study where after reviewing a group of 10,900 older patients admitted to nursing homes, the authors found that the risks of death and femur fracture associated with older antipsychotics, Antidepressants and benzodiazepines are similar to or greater than the risks associated with newer antipsychotics.

Source: Krista F. Huybrechts MS PhD, Kenneth J. Rothman DrPH, Rebecca A. Silliman MD PhD, M. Alan Brookhart PhD, Sebastian Schneeweiss MD ScD, "Risk of death and hospital admission for major medical events after initiation of psychotropic medications in older

 

Drug Study, March 15, 2011

Taiwan

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Stroke,

Summary: American Journal of Psychiatry, published a study that reviewed 24,214 patients with stroke who were enrolled in the National Health Insurance Research Database in Taiwan from 1998 to 2007, and found that Antidepressant use was possibly associated with an increased risk of stroke.

Source: Chi-Shin Wu, M.D., M.Sc., Sheng-Chang Wang, M.D., M.Sc., Yu-Cheng Cheng, M.Sc., and Susan Shur-Fen Gau, M.D., Ph.D, "Association of Cerebrovascular Events With Antidepressant Use: A Case-Crossover Study," American Journal of Psychiatry, March 15, 2011.

 

Drug Study, March 01, 2011

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Drug Toxicity,

Summary: The American Journal of Emergency Medicine published a study which was based on the 699,123 emergency department visits for drug-related poisonings in 2007. The authors found that Antidepressants and analgesics (pain killers) were responsible for nearly 44% of these visits in the US.

Source: Yuxi Xiang, Weiyan Zhao MD, PhD, Huiyun Xiang MD, MPH, PhD, Gary A. Smith MD, DrPH, "ED visits for drug-related poisoning in the United States, 2007," The American Journal of Emergency Medicine, March 2011.

 

Drug Warning, February 22, 2011

United States

Drug Class: Antipsychotic, Antipsychotic and Antidepressant,

Generic Name: Aripiprazole, Clozapine, Iloperidone, Ziprasidone, Haloperidol, Paliperidone, Loxapine, Molindone, Thiothixene, Pimozide, Risperidone, Asenapine, Quetiapine, Trifluoperazine, Chlorpromazine, Olanzapine, Fluoxetine and Olanzapine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine,

Brand Name: Abilify, Clozaril, Fazaclo, Fanapt, Geodon, Haldol, Invega, Loxitane, Moban, Navane, Orap, Risperdal, Saphris, Seroquel, Stelazine, Thorazine, Zyprexa, Symbyax,

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects, Withdrawal Reactions, Involuntary Movement,

Summary: The FDA informed healthcare professionals that it updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs to contain more and consistent information about the potential risk for abnormal muscle movements and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

Source: "FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns," FDA, 22 February 2011.

 

Drug Study, February 22, 2011

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The Journal of Clinical Psychiatry published a study where researchers found that, across all disorders, overall suicidality incidence was similar between paroxetine and placebo. In addition, a higher frequency of suicidal behavior occurred with paroxetine in treatment of major depressive disorder.

Source: David J. Carpenter, MSc, PharmD, et al., "Meta-Analysis of Efficacy and Treatment-Emergent Suicidality in Adults by Psychiatric Indication and Age Subgroup Following Initiation of Paroxetine Therapy: A Complete Set of Randomized Placebo-Controlled Tria

 

Drug Warning, February 01, 2011

Australia

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Death,

Summary: The Australian Therapeutic Goods Administration reported in their safety bulletin that a recent study suggested a higher death rate amongst women taking tamoxifen for breast cancer who were also using the SSRI Antidepressant paroxetine (Paxil). Prescribers need to take caution to when prescribing Antidepressants to women taking tamoxifen.

Source: "Drug interaction between tamoxifen and Antidepressants," Medicines Safety Update, No. 1, 2011.

 

Drug Warning, January 01, 2011

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Pexeva, Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Serotonin Syndrome, Neuroleptic Malignant Syndrome,

Summary: The FDA issued label changes to the Antidepressant Pexeva that warned that adverse reactions such as Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)* like reactions may occur. It also states that these symptoms occur particularly when used with antipsychotics. *Neuroleptic Malignant Syndrome: a life-threatening neurological disorder most often caused by an adverse reaction to antipsychotic drugs. High fever, sweating, rigidity, blood pressure changes, confusion, coma, and sometimes death are caused.

Source: "Pexeva (paroxetine mesylate) tablets January 2009", FDA, April 2011, http://www.fda.gov/Safety/MedWatch/safetyInformation/Safety-RelatedD...

 

Drug Study, December 01, 2010

Finland

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Wieght Gain, Diabetes,

Summary: A study published in Diabetes Care found that after researcher's analyzed over 150,000 people in Finland, exposure to Antidepressants could double one's risk of type 2 diabetes. This risk was dose dependent - the higher the dose, the larger the risk.

Source: Mika Kivimaki, Mark Hamer, G. David Batty, John R. Geddes, Adam G. Tabak, Jaana Pentti, Marianna Virtanen and Jussi Vahtera, "Antidepressant Medication Use, Weight Gain, and Risk of Type 2 Diabetes. A population-based study," Diabetes Care, Dec. 2010,

 

Drug Warning, December 01, 2010

United States

Drug Class: Antipsychotic, Antipsychotic and Antidepressant,

Generic Name: Aripiprazole, Clozapine, Iloperidone, Ziprasidone, Haloperidol, Paliperidone, Molindone, Thiothixene, Pimozide, Quetiapine, Olanzapine, Fluoxetine and Olanzapine,

Brand Name: Geodon, Haldol, Invega, Moban, Navane, Orap, Saphris, Seroquel, Symbyax, Zyprexa, Abilify, Clozaril, Fanapt, Fazaclo,

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects, Sleepiness, Agitation, Abnormally Tight Muscles, Hypotonia, Seizures, Respiratory Problems, Eating Disorder, Tremors,

Summary: The FDA issued label changes to the safety information on antipsychotics to warn that newborns exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for abnormal muscle movements and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia (abnormal increase in muscle tightness), hypotonia (abnormal decrease in muscle tone - floppy), tremor, somnolence, respiratory distress and feeding disorder in these newborns. Some cases have required intensive care unit support and prolonged hospitalization.

Source: "Risk of EPS and Withdrawal Syndrome in Neonates December 2010 Label Changes for Antipsychotics," FDA MedWatch, Dec. 2010.

 

Drug Study, December 01, 2010

United States

Drug Class: Mood Stabilizer, Antianxiety, Antidepressant, Antipsychotic, Stimulant,

Generic Name: Fluoxetine, Paroxetine, Fluvoxamine, Venlafaxine, Desvenlafaxine, Sertraline, Escitalopram, Citalopram, Amitriptyline, Bupropion, Trazodone, Mirtazapine, Duloxetine, Amphetamines, Atomoxetine, Methylphenidate, Levetiracetam, Oxcarbazepine, Topiramate, Lamotrigine, Valproic Acid, Phenytoin, Carbamazepine, Aripiprazole, Ziprasidone, Risperidone, Quetiapine, Olanzapine, Paliperidone, Clozapine, Triazolam, Zolpidem, Eszopiclone, Diazepam, Alprazolam, Clonazepam, Midazolam, Lorazepam,

Brand Name: Prozac, Paxil, Seroxat, Luvox, Effexor, Pristiq, Zoloft, Lexapro, Celexa, Elavil, Endep, Vanatrip, Wellbutrin, Zyban, Desyrel, Oleptro, Remeron, Cymbalta, Strattera, Ritalin, Concerta, Keppra, Trileptal, Topamax, Topiragen, Lamictal, Depakote, Depakene, Depacon, Epilim, Di-Phen, Dilantin, Phenytek, Carbatrol, Epitol, Equetro, Tegretol, Abilify, Geodon, Risperdal, Seroquel, Zyprexa, Invega, Clozaril, Halcion, Ambien, Lunesta, Valium, Xanax, Klonopin, Versed, Ativan,

Age: Adults (18 and over), Children (under 18)

Side Effects: Violence, Homicidal Ideation, Homicidal Actions,

Summary: The authors of a study in PLoS One took the Food and Drug Administration's Adverse Event Reporting System data, and extracted all "serious adverse event" reports for drugs with 200 or more cases received from 2004 through September 2009. They identified 484 drugs, which accounted for 780,169 serious adverse event reports of all kinds, including 1,937 cases meeting their violence criteria. Of the 484 drugs identified, 31 drugs were disproportionately associated with violence. These drugs, accounting for 79% of all the violence cases, included 11 Antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The specific cases of violence included: homicide, physical assaults, cases indicating physical abuse, homicidal ideation, and cases described as violence-relates symptoms. The authors concluded, "These data provide new evidence that acts of violence towards others are a genuine and serious adverse drug event that is associated with a relatively small group of drugs.

Source: Thomas J. Moore, Joseph Glenmullen, Curt D. Furbert, "Prescription Drugs Associated with Reports of Violence Towards Others," Public Library of Science ONE, Vol. 5, Iss. 12, Dec. 2010.

 

Drug Warning, December 01, 2010

Australia

Drug Class: Antidepressant, Mood Stabilizer,

Generic Name: Lithium,

Brand Name: Eskalith, Eskalith CR, Lithobid,

Age: Adults (18 and over)

Side Effects: Serotonin Syndrome, Confusion, Agitation, Restlessness, Skin Problems, Cardiac Events, Skin Reactions,

Summary: The Australian Therapeutic Goods Administration issued in their Medicines Safety Update Bulletin a 'reminder' on Serotonin Syndrome to warn that certain drugs including lithium and certain types of Antidepressants (SSRIs, MAOIs, tricyclics and SNRIs) can cause Serotonin Syndrome. Early signs and symptoms can be mild, yet life-threatening. Symptoms include: altered mental states - confusion, agitation, restlessness and excitement, as well as physical manifestations such as shivering, flushing, tachycardia (increased heart rate) and hyperthermia (elevated body temperature).

Source: "Serotonin syndrome: a reminder," Medicines Safety Update, No. 6, December 2010.

 

Drug Study, November 01, 2010

Scotland

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Heart Problems,

Summary: The European Heart Journal published an 8-year follow up study on 14,784 adults without any history of cardiovascular disease (CVD). They found an increased risk of CVD in those taking older Antidepressants. They also found that this risk was not associated with any mental illness, therefore discrediting the idea that the mental illness causes an increase risk of CVD.

Source: Mark Hamer, G. David Batty, Adrie Seldenrijk and Mika Kivimak, "Antidepressant medication use and future risk of cardiovascular disease: the Scottish Health Survey," European Heart Journal, Nov. 2010.

 

Drug Study, October 12, 2010

Germany

Drug Class: Antidepressant,

Generic Name: Reboxetine,

Brand Name: Edronax , Vestra,

Age: Adults (18 and over)

Side Effects: Lack of Efficacy,

Summary: The British Medial Journal published a study where researchers concluded, "Reboxetine is, overall, an ineffective and potentially harmful Antidepressant."

Source: Dirk Eyding, Monika Lelgemann, Ulrich Grouven, Martin Harter, Mandy Kromp, Thomas Kaiser, Michaela F Kerekes, Martin Gerken, Beate Wieseler, "Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpub

 

Drug Study, October 05, 2010

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Lack of Efficacy,

Summary: Researchers published a study in Journal of Clinical Psychiatry that found that Antidepressants were not statistically superior to placebo or other current standard treatment for bipolar depression, concluding that Antidepressants' lack of efficacy may limit their clinical utility.

Source: M. M. Sidor and G. M. Macqueen, "Antidepressants for the acute treatment of bipolar depression: a systematic review and meta-analysis," Journal of Clinical Psychiatry, 5 Oct. 2010.

 

Drug Warning, September 01, 2010

New Zealand

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Paroxetine,

Brand Name: Prozac, Paxil, Seroxat,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects, Heart Problems, Withdrawal Reactions, Premature Birth, Lung Problems,

Summary: MedSafe (NZ) issued information in their Prescribe Update publication about the use of Antidepressants during pregnancy. The Medicines Adverse Reactions Committee (after reviewing studies on SSRIs and SNRIs) concluded that there is a small increased risk of heart birth defects associated with fluoxetine (Prozac), similar to that seen with paroxetine (Paxil). Also, there is a possibility of this increased risk for all SSRIs or SNRIs (not just Paxil and Prozac). In addition to the risk of birth defects, SSRIs and SNRIs have been associated with an increase in risk of pre-term birth, persistent pulmonary hypertension of the newborn (little or no blood flow into an infants lungs after birth) and newborn withdrawal symptoms.

Source: "The use of Antidepressants in pregnancy," Prescriber Update, MedSafe, Vol. 31, No. 3, Sept. 2010.

 

Drug Study, August 24, 2010

United States

Drug Class: Antidepressant,

Generic Name: Sertraline,

Brand Name: Zoloft,

Age: Adults (18 and over)

Side Effects: Lack of Efficacy ,

Summary: A study was published in the Journal of the American College of Cardiology that found that treatment with the Antidepressant sertraline (Zoloft) "compared with placebo did not provide greater reduction in depression... among patients with heart failure and depression."

Source: Christopher M. O'Connor, Wei Jiang, Maragatha Kuchibhatla, Susan G. Silva, Michael S. Cuffe, Dwayne D. Callwood, Bosh Zakhary, Wendy Gattis Stough, Rebekka M. Arias, Sarah K. Rivelli, and Ranga Krishnan, "Safety and Efficacy of Sertraline for Depressio

 

Drug Study, July 13, 2010

Canada

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18), Adults (18 and over)

Side Effects: Death, Sudden Death,

Summary: The authors of a study in the Canadian Medical Association Journal reviewed the risk of spontaneous abortion in relation to Antidepressant use during pregnancy. Based on the Quebec Pregnancy Registry, they found 284 women who had an abortion and at least one prescription for an Antidepressant during her pregnancy. Based on their review, they found, "The use of Antidepressants, especially paroxetine, venlafaxine or the combined use of different classes of Antidepressants, during pregnancy was associated with an increased risk of spontaneous abortion."

Source: Hamid Reza Nakhai-Pour MD PhD, Perrine Broy BSc, Anick Berard PhD, "Use of Antidepressants during pregnancy and the risk of spontaneous abortion," Canadian Medical Association Journal, Vol. 182, No. 10, 12 Jul 2010.

 

Drug Study, June 23, 2010

Denmark

Drug Class: Antianxiety, Mood Stabilizer, Antidepressant, Antipsychotic, Stimulant,

Generic Name: Levomepromazine, Ziprasidone, Zuclopenthixol, Chlorprothixene, Clozapine, Olanzapine, Quetiapine, Sulpiride, Risperidone, Aripiprazole, Diazepam, Oxazepam, Buspirone, Chloral hydrate, Midazolam, Imipramine, Clomipramine, Amitriptyline, Fluoxetine, Citalopram, Paroxetine, Sertraline, Escitalopram, Mirtazapin, Venlafaxine, Methylphenidate, Modafinil, Atomoxetine,

Brand Name: Nozinan, Geodon, Cisordinol, Clopixol, Acuphase, Cloxan, Taractan, Truxal, Clozaril, Zyprexa, Seroquel, Sulpitil, Risperdal, Abilify, Valium, Serax, Buspar, Aquachloral Supprettes, Somnote, Versed, Tofranil, Anafranil, Elavil, Endep, Vanatrip, Prozac, Celexa, Paxil, Seroxat, Zoloft, Lexapro, Remeron, Effexor, Ritalin, Concerta, Daytrana, Provigil, Strattera,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: A study in BioMed Central, Ltd., showed how the prescribing of psychotropic drugs in infants is rapidly increasing. In attempts to curb the use of these drugs, regulatory authorities have issued various warnings about risks associated with use of these products in childhood. This team of researchers analyzed data submitted to a national adverse drug reactions (ADR) database to categorize ADRs reported for psych drugs in the Danish pediatric population. They found that almost 20% of psychotropic ADRs were reported for children from birth up to 2 years of age and one half of ADRs were reported in adolescents. The authors concluded that, "The high number of serious ADRs reported for psychotropic medicines in the pediatric population should be a concern for health care professionals and physicians. Considering the higher number of birth defects being reported greater care has to be given while prescribing these drugs for pregnant women."

Source: Lise Aagaard and Ebba H Hansen, "Adverse drug reactions from psychotropic medicines in the paediatric population: analysis of reports to the Danish Medicines Agency over a decade," BioMed Central Ltd., vol. 3, no. 176, June 23, 2010.

 

Drug Study, May 27, 2010

Canada

Drug Class: Mood Stabilizer, Antidepressant, Antianxiety,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Lowered Bone Mineral Density, Lowered Bone Mass,

Summary: A presentation of a study at the 2010 American Psychiatric Association meeting by Dr. James Bolton of a large study from Canada found that osteoporosis was associated with the use of selective serotonin reuptake inhibitors (SSRIs), mood stabilizers other than lithium, and benzodiazepines. "We found a 40% increased risk for low [bone mineral density] with SSRIs and a 37% reduced risk with tricyclic Antidepressants," said James Bolton, MD, of the University of Manitoba in Winnipeg, Canada.

Source: Caroline Helwick, "Many Psychotropic Medications May Be Bad for Bones," MedScape, May 27, 2010, http://www.medscape.com/viewarticle/722600 citing: "Abstract NR4-5" a presentation of a study at the 2010 American Psychiatric Association meeting by Dr

 

Drug Study, May 01, 2010

Canada

Drug Class: Antidepressant,

Generic Name: Citalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Venlafaxine, Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Maprotiline, Nortriptyline, Protriptyline, Trimipramine, Mirtazapine, Nefazodone, Trazodone, Moclobemide, Phenelzine, Tranylcypromine,

Brand Name: Celexa, Prozac, Luvox, Paxil, Seroxat, Zoloft, Effexor, Elavil, Endep, Vanatrip, Asendin, Anafranil, Norpramin, Pertofrane, Adapin, Silenor, Sinequan, Tofranil, Ludiomil, Aventyl, Pamelor, Vivactil, Surmontil, Remeron, Serzone, Desyrel, Oleptro, Aurorix, Manerix, Nardil, Parnate,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The Archives of General Psychiatry published a study that compared the risk of suicide and suicide attempts associated with specific Antidepressants. After reviewing Canadian health care records, they found that equal event rates across Antidepressant agents supports the US FDA's decision to treat all Antidepressants alike in their advisory on Antidepressants increasing the risk of suicidal thoughts and behavior.

Source: Sebastian Schneeweiss, MD, et al., "Variation in the Risk of Suicide Attempts and Completed Suicides by Antidepressant Agent in Adults," Archives of General Psychiatry, vol. 67, no. 5, May 2010.

 

Drug Warning, May 01, 2010

United Kingdom

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects, High Blood Pressure,

Summary: UK's Medicines and Healthcare products Regulatory Agency issued a warning about the use of SSRIs in pregnancy, particularly in the later stages, may increase the risk of persistent high blood pressure in the arteries of the lungs in the newborn.

Source: "SSRIs and SNRIs: risk of persistent pulmonary hypertension in the newborn," Drug Safety Updates, Medicines and Healthcare products Regulatory Agency, Vol. 3, Iss. 10, May 2010, p. 2.

 

Drug Study, May 01, 2010

Australia

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects, Premature Birth,

Summary: A study in Australian and New Zealand Journal of Psychiatry looked at whether newborn outcomes, including age at birth, growth at birth and then at 1 month, were altered by exposure to Antidepressants during pregnancy. They found that Antidepressant exposure during pregnancy resulted in an eightfold increase in chance of being born premature, and with a smaller birth weight. This association was not found with depressed mothers. In addition, at 1 moth in age, the difference in weight in the exposed group became significantly greater then those not exposed to Antidepressants.

Source: Andrew J. Lewis, et al, "Neonatal growth outcomes at birth and one month postpartum following in utero exposure to Antidepressant medication," Australian and New Zealand Journal of Psychiatry, Vol. 44, No. 5, May 2010.

 

Drug Warning, May 01, 2010

United Kingdom

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Fractures,

Summary: UK's Medicines and Healthcare products Regulatory Agency issued a warning on the risk of Antidepressants causing fractures. Studies have shown that there is an increase risk of bone fractures in patients receiving SSRIs or Tricyclic Antidepressants, especially those 50 years and older.

Source: "Antidepressants: risk of fractures," Drug Safety Updates, Medicines and Healthcare products Regulatory Agency, Vol. 3, Iss. 10, May 2010, p. 3.

 

Drug Study, April 26, 2010

Canada

Drug Class: Antidepressant,

Generic Name: Bupropion,

Brand Name: Wellbutrin, Zyban,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: The American Journal of Obstetrics and Gynecology published a study that researched whether maternal bupropion (Antidepressant) treatment in early pregnancy is associated with birth heart defects in the infant. They found that mother's of infants with left outflow tract heart defects were more likely to have reported taking bupropion. The authors concluded that there is an association between early pregnancy bupropion use and left outflow tract heart defects.

Source: Alwan S, Reefhuis J, Botto LD, et al., Maternal use of bupropion and risk for congenital heart defects. Am J Obstet Gynecol 2010;202:x.ex-x.ex.

 

Drug Study, April 12, 2010

Canada

Drug Class: Antidepressant,

Generic Name: Citalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Venlafaxine, Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Maprotiline, Nortriptyline, Protriptyline, Trimipramine, Mirtazapine, Nefazodone, Trazodone, Moclobemide, Phenelzine, Tranylcypromine,

Brand Name: Celexa, Prozac, Luvox, Paxil, Seroxat, Zoloft, Effexor, Elavil, Endep, Vanatrip, Asendin, Anafranil, Norpramin, Pertofrane, Adapin, Silenor, Sinequan, Tofranil, Ludiomil, Aventyl, Pamelor, Vivactil, Surmontil, Remeron, Serzone, Desyrel, Oleptro, Aurorix, Manerix, Nardil, Parnate,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: A study published in Pediatrics was done on 20,906 children from British Columbia (BC), who were new users of Antidepressants, of which 16,777 (80%) had never used an Antidepressant before. The children were aged 10 to 18, and had a recorded diagnosis of depression. During the 9-year study period, the suicide risk among all BC kids aged 13 to 17 averaged 0.052 suicide deaths per 1,000 people. The rate of suicides that the authors observed after initiation of Antidepressant use, was 5 times higher. However, they attribute this to the "current depressed state and greater degree of psychiatric comorbidity in our population." The authors concluded: "Our analysis supports the decision of the Food and Drug Administration to include all Antidepressants in the black box warning regarding increased suicidality risk for children and adolescents initiating use of Antidepressants."

Source: Sebastian Schneeweiss, et al., "Comparative Safety of Antidepressant Agents for Children and Adolescents Regarding Suicidal Acts," Pediatrics, April 12, 2010.

 

Drug Study, March 05, 2010

Australia

Drug Class: Antidepressant, Antipsychotic,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Weight Gain,

Summary: Research was reported at the Anxiety Disorders Association of America 30th Annual Conference regarding the obesity rate among individuals taking Antidepressants. The research showed that the obesity rate among individuals taking Antidepressants during the past 12 months was 1.5 times greater compared with individuals not taking these drugs. In addition, the obesity rate among subjects taking antipsychotics was more than double.

Source: Crina Frincu-Mallos, PhD, "Psychotropic Medications Linked to Increased Rates of Obesity," Medscape, March 8, 2010.

 

Drug Study, March 01, 2010

Denmark

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Citalopram, Paroxetine, Sertraline, Venlafaxine,

Brand Name: Prozac, Celexa, Paxil, Seroxat, Zoloft, Effexor,

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects,

Summary: The journal Pediatrics published a study that investigated the possible association between Antidepressant exposure to the fetus during pregnancy and normal milestone developments at 6 and 19 months. Their concluding research found that exposure to Antidepressant affected fetal brain development.

Source: Lars Henning Pedersen, MD, et al., "Fetal Exposure to Antidepressants and Normal Milestone Development at 6 and 19 Months of Age," PEDIATRICS, Vol. 125, No. 3, March 3, 2010.

 

Drug Warning, March 01, 2010

United Kingdom

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects, Heart Problems,

Summary: UK's Medicines and Healthcare products Regulatory Agency (MHRA) published in Drug Safety Update warning that there is an increased risk of heart birth defects with the use of Antidepressant fluoxetine in the first three months of pregnancy, similar to that seen with paroxetine.

Source: "Fluoxetine: possible small risk of congenital cardiac defects," Drug Safety Updates, Medicines and Healthcare products Regulatory Agency, Vol. 3, Iss. 8, March 2010.

 

Drug Warning, March 01, 2010

Ireland

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects, Heart Problems,

Summary: The Irish Medicines Board published in there Drug Safety Newsletter, a report warning about the increased risk of heart birth defects and the use of fluoxetine in the first three months of pregnancy. This was based on the European Medicines Agency analysis of the subject, which included nine studies. They found that the risk of having a baby born with a cardiovascular birth defect following the use of fluoxetine during the first trimester is slightly increased.

Source: "Fluoxetine and risk of cardiovascular birth defects," Drug Safety, Irish Medicines Board, Iss. 36, March 2010.

 

Drug Study, February 26, 2010

Denmark

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Death, Sudden Death,

Summary: The International Journal of Cardiology published a study that assessed whether Antidepressant treatment for depression was associated with increased death risk in patients with heart contraction failure. Their data suggested that pharmacologically treated depression was associated with a 49% increased mortality risk.

Source: Karsten T. Veien, et al., "High mortality among heart failure patients treated with Antidepressants," International Journal of Cardiology, February 26, 2010.

 

Drug Study, February 08, 2010

United Kingdom

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Death, Sudden Death,

Summary: The British Medical Journal published a study on the mortality rates of women using SSRIs while receiving Tamoxifen treatment for breast cancer. The authors concluded that Paroxetine use during Tamoxifen treatment is associated with an increased risk of death from breast cancer.

Source: Catherine M. Kelly, et al "Selective serotonin reuptake inhibitors and breast cancer mortality in women receiving tamoxifen: a population based cohort study" British Medical Journal, February 8, 2010.

 

Drug Warning, February 01, 2010

United States

Drug Class: Antidepressant,

Generic Name: Desvenlafaxine,

Brand Name: Pristiq,

Age: Adults (18 and over)

Side Effects: Abnormal Bleeding, Hallucinations, Skin Reactions,

Summary: The FDA updated the warning label for Pristiq to include that adverse reactions may occur with desvenlafaxine such as: gastrointestinal bleeding, hallucinations, and photosensitivity reactions.

Source: "Prozac (flluoxetine hydrochloride), Detailed View: Safety Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)" FDA, April 2011, http://www.fda.gov/Safty/MedWatch/SafetyInformation/ucm255402.htm

 

Drug Study, January 05, 2010

Sweden

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: Authors of a study published in Psychological Medicine investigated possible adverse effects of the use of Antidepressant medication during pregnancy. They reviewed 14,821 women from the Swedish Medical Birth Register. The researchers found that there was an association between Antidepressant treatment and many pregnancy complications, notably after tricyclic Antidepressant use. An association between use of paroxetine and birth heart defects and urinary tube defects was also found. The authors concluded that women using Antidepressants during pregnancy and their newborns have an increase in health issues.

Source: M. Reis, and B. Kallen, "Delivery outcome after maternal use of Antidepressant drugs in pregnancy: an update using Swedish data," The Psychological Medicine, 1-11, [Epub ahead of print], Jan. 5, 2010.

 

Drug Warning, January 01, 2010

United States

Drug Class: Antipsychotic, Antidepressant,

Generic Name: Fluoxetine and Olanzapine,

Brand Name: Symbyax,

Age: Adults (18 and over)

Side Effects: Creatine Phosphokinase (CPK) Increased Levels,

Summary: The U.S. FDA added precautions to Symbyax's drug package insert, of an increase in Creatine Phosphokinase (CPK), which is an enzyme found mainly in the heart, brain, and skeletal muscle, reported with use of this drug. When the CPK level is very high, it usually means there has been injury or stress to the heart, the brain, or muscle tissue.

Source: "Symbyax (olanzapine and fluoxetine hydrochloride) capsule," FDA Medwatch January 2010, http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm200254.htm.

 

Drug Study, January 01, 2010

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine, Venlafaxine,

Brand Name: Paxil, Seroxat, Effexor,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects, Death, Sudden Death,

Summary: A study published in Current Drug Delivery researched the "under evaluated" impact of Antidepressant use during pregnancy on the risk of spontaneous abortion. After reviewing the data collected, they said the information suggests fetal exposure to Antidepressants, especially paroxetine and venlafaxine, can lead to spontaneous abortion.

Source: Broy, Perrine and Berard, Anick., "Gestational Exposure to Antidepressants and the Risk of Spontaneous Abortion: A Review," Current Drug Delivery, Vol. 7, No. 1, January 2010.

 

Drug Warning, January 01, 2010

United States

Drug Class: Antidepressant,

Generic Name: Venlafaxine,

Brand Name: Effexor,

Age: Adults (18 and over)

Side Effects: Seizures, Tremors, Nausea, Vomiting, Skin Problems, Skin Reactions, Dizziness, Death, Sudden Death,

Summary: The FDA updated the warning label for Effexor stating that it should not be taken by patients taking or have taken MAOIs (monoamine oxidase inhibitors, used to treat depression) within 14 days due to the risk of serious, sometimes fatal, drug interactions with SNRI or SSRI treatment. Some symptoms include tremor, nausea, vomiting, flushing, dizziness.

Source: "Effexor (venlafaxineHCI) tablets and Effexor XR (venlafaxine HCI) extended-release capsule" FDA.gov, January 2010, http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm201064.htm

 

Drug Study, January 01, 2010

United States

Drug Class: Antidepressant, Antipsychotic,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Lack of Efficacy,

Summary: The authors of a study in Archives of General Psychiatry found that there has been a significant increase in polypharmacy (prescribing of multiple drugs together) involving Antidepressant and antipsychotic medications. This type of polypharmacy has unproven efficacy, and puts patients at increased risk of drug to drug interactions without any evidence of improved quality of care.

Source: Ramin Mojtabai, MD, PhD, MPH and Mark Olfson, MD, MPH, "National Trends in Psychotropic Medication Polypharmacy in Office-Based Psychiatry," Archives of General Psychiatry, Vol. 67, No. 1, January 2010.

 

Drug Study, December 17, 2009

United States

Drug Class: Mood Stabilizer, Antianxiety, Antidepressant, Antipsychotic, Stimulant,

Generic Name:

Brand Name:

Age: Children (under 18)

Side Effects: Lack of Efficacy,

Summary: The Journal of Marital and Family Therapy released a study that warned of the dramatic rise in the use of psychotropic medications for children. The authors stated that there is little evidence available to warrant the widespread use of psychotropic drugs for children, and little long-term data regarding the drug's long-term impact on a child's development. They further state that the pharmaceutical industry is largely influenced by the desire for economic profit, the marketing muscle behind the industry and leniency of institutions such as the FDA. Also, that they tout benefits not yet properly evaluated for pediatric use.

Source: "December 17, 2009.

 

Drug Study, December 14, 2009

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Heart Problems, Death, Sudden Death,

Summary: The Archives of Internal Medicine published a study that researched the relationship between Antidepressants and the start of problems related to the heart and blood vessels in postmenopausal women. The researchers found that tricyclic and SSRIs Antidepressants may be associated with increased risk of mortality. SSRIs additionally show an increased risk of excessive bleeding and fatal stroke.

Source: Jordan W. Smoller, MD, et al., "Antidepressant Use and Risk of Incident Cardiovascular Morbidity and Mortality Among Postmenopausal Women in the Women's Health Initiative Study," Archives of Internal Medicine, Vol. 169, No. 22, December 14, 2009.

 

Drug Study, December 04, 2009

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Lactating Problems,

Summary: The Journal of Clinical Endocrinology and Metabolism published a study that found mothers who took drugs that affected serotonin levels (such as SSRI Antidepressants) may experience difficulty in breastfeeding.

Source: Aaron M. Marshall, et al, "Serotonin Transport and Metabolism in the Mammary Gland [milk-secreting gland] Modulates Secretory Activation and Involution [reduction in size of an organ or part]," Journal of Clinical Endocrinology & Metabolism, December 4,

 

Drug Study, December 01, 2009

United States

Drug Class: Mood Stabilizer, Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects, Premature Birth,

Summary: A study in the American Journal of Obstetrics & Gynecology looked at the effects of psychiatric drugs taken during pregnancy on fetal outcomes. It found that benzodiazepines were highly associated with preterm delivery and other adverse pre-birth outcomes. Selective serotonin receptor inhibitors were associated with preterm deliveries when women started treatment after the first trimester. They researchers recommend more studies about risks and benefits of psychotropic medication use during pregnancy.

Source: Ronit Calderon-Margalit, MD, MPH, et al., "Risk of preterm delivery and other adverse perinatal outcomes in relation to maternal use of psychotropic medications during pregnancy" American Journal of Obstetrics & Gynecology, Vol. 201, Iss. 6, Pages 579-

 

Drug Study, November 01, 2009

United Kingdom

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Heart Problems, Death, Sudden Death,

Summary: The European Journal of Clinical Pharmacology published a study that evaluated the risk of heart problems in patients (with no prior history of heart risks) after taking an Antidepressant. They found that in general, drug treatment for depression was associated with an increase in mortality and major heart problems.

Source: S. Monte, et al., "Antidepressants and cardiovascular outcomes in patients without known cardiovascular risk," European Journal of Clinical Pharmacology, Vol. 65, No. 11, November 2009.

 

Drug Study, October 01, 2009

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over), Children (under 18)

Side Effects: Premature Birth,

Summary: A study in Archives of Pediatric & Adolescent Medicine investigated the pregnancy outcomes of babies exposed to SSRIs in the womb. They compared 329 pregnant women treated with SSRIs, 4,902 were not treated with SSRIs but having a history of psychiatric illness, and 51,770 who reported no history of psychiatric illness. The researchers found that fetal exposure to SSRIs during pregnancy was associated with an increased risk of preterm delivery, and neonatal intensive care unit admission.

Source: Najaaraq Lund, MD, et al., "Selective Serotonin Reuptake Inhibitor Exposure In Utero and Pregnancy Outcomes," Archives of Pediatric & Adolescent Medicine, Vol. 163, No. 10, October 2009.

 

Drug Study, September 23, 2009

United Kingdom

Drug Class: Antidepressant,

Generic Name: Sertraline, Citalopram, Fluoxetine,

Brand Name: Zoloft, Celexa, Prozac,

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects, Heart Problems,

Summary: A study published in the British Medical Journal reviewed the chances of SSRIs causing birth defects when taken during pregnancy. The authors found a significant increase in risk of septal [the muscle wall that divides the heart chambers] heart defects among children who's mothers took SSRIs during pregnancy, particularly with sertraline and citalopram. This risk nearly doubled when more then one SSRI was taken.

Source: Lars Henning Pedersen, et al, "Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study," British Medical Journal, Vol. 339, September 23, 2009.

 

Drug Study, September 01, 2009

Canada

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects,

Summary: The journal Current Drug Safety published a study that found when pregnant women used paroxetine during the embryonic development of their baby's organs, there was a link to an increase in the risk of heart malformations.

Source: Simoncelli M, Martin BZ, Brard A, "Antidepressant Use during Pregnancy: A Critical Systematic Review of the Literature," Current Drug Safety, September 1, 2009.

 

Drug Study, August 18, 2009

Canada

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over), Children (under 18)

Side Effects: Premature Birth,

Summary: The journal Depression and Anxiety published a study that found that the use of Antidepressants in pregnancy appears to be associated with a small, but statistically significant, increase in preterm births, confirming results from several other studies.

Source: A. Einarson, R.N., et al., "Adverse effects of Antidepressant use in pregnancy: an evaluation of fetal growth and preterm birth," Depression and Anxiety, August 18, 2009.

 

Drug Study, August 14, 2009

Netherlands

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects,

Summary: "The journal BJOG: An International Journal of Obstetrics & Gynaecology published a study that found children of mothers who used Antidepressants during pregnancy showed increased healthcare use during the first year of life, independent of the mother's healthcare use, and had an increased risk of major cardiac interventions such as cardiovascular surgery or heart catheterization in early childhood."

Source: TF Ververs, et al., "Association between Antidepressant drug use during pregnancy and child healthcare utilization," BJOG: An International Journal of Obstetrics & Gynaecology, August 14, 2009.

 

Drug Warning, August 01, 2009

Australia

Drug Class: Antidepressant,

Generic Name: Duloxetine,

Brand Name: Cymbalta,

Age: Adults (18 and over)

Side Effects: Serotonin Syndrome, Suicide Risk, Suicide Attempts, Suicide, Agitation, Irritability,

Summary: The Australian Therapeutic Goods Administration issued an Adverse Drug Reactions Bulletin to warn that the Antidepressant duloxetine (Cymbalta) can cause serotonin syndrome (which occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea). The Australian Therapeutic Goods Administration said they have had 108 reports of suspected adverse reactions for duloxetine from June 2008 to May 2009, including 10 cases of suicidal ideation and 8 cases of agitation. Based on the evidence, they said that serotonin syndrome can occur with duloxetine treatment alone even at normal doses, as well as in combination with other drugs known to cause this syndrome. The Product Information for duloxetine has been updated to include this information.

Source: "Serotonin syndrome with duloxetine," Australian Adverse Drug Reactions Bulletin, Volume 28, Number 4, August 2009.

 

Drug Study, July 14, 2009

Australia

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Coronary Heart Disease,

Summary: The International Journal of Cardiology published a study on the association between Antidepressant use and incident coronary heart disease (CHD - narrowing of small blood vessels that supply blood to the heart) events in a sample of healthy individuals. The authors found that exposure to tricyclic Antidepressants was associated with higher risk of first CHD events.

Source: Rosenberg LB, et al., "Exposure to tricyclic Antidepressants is associated with an increased risk of incident CHD events in a population-based study," The International Journal of Cardiology, July 14, 2009.

 

Drug Warning, July 01, 2009

United States

Drug Class: Antidepressant, Antianxiety,

Generic Name: Bupropion,

Brand Name: Zyban, Wellbutrin,

Age: Adults (18 and over)

Side Effects: Abnormal Behavior, Emotional Changes, Aggression, Violence, Hostility, Agitation, Irritability, Depression, Suicide Risk, Suicide Attempts, Suicide,

Summary: The FDA has required the manufacturers of the smoking cessation aid bupropion (Zyban, aka Wellbutrin) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using this product. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.

Source: "Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)," FDA, July 1, 2009.

 

Drug Study, June 10, 2009

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Sperm Count Decreased, Fertility Potential Decreased, Sexual Dysfunction,

Summary: The journal Fertility & Sterility published a study that assessed the effects of a selective serotonin reuptake inhibitor on semen amounts. In men with normal semen parameters (overall quantity), paroxetine induced abnormal sperm DNA fragmentation in a significant proportion of subjects, without a measurable effect on semen parameters. The fertility potential of a substantial number of men on paroxetine may be adversely affected by these changes in sperm DNA integrity.

Source: Cigdem Tanrikut, M.D., et al., "Adverse effect of paroxetine on sperm," Fertility & Sterility, June 10, 2009.

 

Drug Study, June 01, 2009

United States

Drug Class: Antidepressant,

Generic Name: Sertraline, Venlafaxine, Citalopram, Paroxetine, Fluoxetine, Imipramine, Phenelzine, Duloxetine, Escitalopram,

Brand Name: Zoloft, Effexor, Celexa, Paxil, Seroxat, Prozac, Tofranil, Nardil, Cymbalta, Lexapro,

Age: Adults (18 and over)

Side Effects: Sperm Count Decreased, Fertility Potential Decreased , Sexual Dysfunction,

Summary: The Journal of Clinical Psychopharmacology published a study that aimed to calculate sexual dysfunction (SD) caused by Antidepressants on the basis of studies where sexual functioning was purposely investigated through direct inquiry and specific questionnaires. The authors concluded, "Treatment-emergent SD is a frequent adverse effect [of some Antidepressants]..."

Source: Serretti, A., Chiesa A., "Treatment-emergent Sexual Dysfunction Related to Antidepressants: A Meta-Analysis," The Journal of Clinical Psychopharmacology, Vol. 29, Is. 3, pp 259-66, June 2009.

 

Drug Study, June 01, 2009

United States

Drug Class: Antidepressant,

Generic Name: Citalopram,

Brand Name: Celexa,

Age: Children (under 18)

Side Effects: Hyperactivity, Impulsiveness, Decreased Concentration, Diarrhea, Sleep Problems, Insomnia, Dry skin,

Summary: The Archives of General Psychiatry published a study that found that in children citalopram was more likely to be associated with adverse reactions such as impulsiveness, decreased concentration, hyperactivity, diarrhea, insomnia, and dry skin. This is opposed to the group treated with a placebo.

Source: Bryan H. King, MD, et al., "Lack of Efficacy of Citalopram in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior. Citalopram Ineffective in Children With Autism," Archives of General Psychiatry, Vol. 66, No. 6, June 2009.

 

Drug Study, May 14, 2009

Finland

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Heart Problems, Cardiac Events,

Summary: In a study released at the Heart Rhythm Society's Annual meeting, Finland researchers discovered that people who suffered fatal cardiac arrest were more likely to have taken Antidepressants and other psychiatric drugs than those who survived heart attacks.

Source: "Psychiatric Drugs Might Raise Cardiac Death Risk," HealthDay News, www.14wfie.com, May 14, 2009, citing: Jussi Honkola, M.D., Researcher, University of Oulu, Finland and Robert A. Harrington, M.D., Professor, Medicine, Division of Cardiology

 

Drug Study, May 04, 2009

Netherlands

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Heart Problems, Cardiac Events,

Summary: Psychosomatic Medicine published a study that sought to determine whether patients with different types of anxiety disorder had a higher heart rate and lower heart rate variable compared to healthy controls. The authors concluded: "This study shows that anxiety disorders are associated with significantly lower HR [heart rate] variability, but the association seems to be driven by the effects of Antidepressants."

Source: Carmilla M. M. Licht , MSc, Eco J. C. de Geus , PhD, et al.., "Association between Anxiety Disorders and Heart Rate Variability in The Netherlands Study of Depression and Anxiety (NESDA)," Psychosomatic Medicine, May 4, 2009.

 

Drug Warning, May 01, 2009

Japan

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Aggression, Violence, Hostility, Anxiety, Panic Attacks,

Summary: The Japanese Ministry of Health, Labor and Welfare investigated news reports of Antidepressant users "who developed increased feelings of hostility or anxiety, and have even committed sudden acts of violence against others." After its investigation, the Ministry decided to revise the label warnings on newer Antidepressants stating, "There are cases where we cannot rule out a causal relationship [of hostility, anxiety, and sudden acts of violence] with the medication."

Source: "Japan Revises SSRI Warnings--Hostility, Violence," Medical News Today, May 28, 2009.

 

Drug Study, May 01, 2009

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Sperm Count Decreased, Fertility Potential Decreased, Sexual Dysfunction,

Summary: The Journal of Sexual Medicine published a study that sought to assess any relationship between Antidepressants and benzodiazepines, with sexual dysfunction in males with symptoms of a comparable mental disorder. The authors discovered that newer Antidepressants could negatively affect all the steps of the male sexual response cycle (desire-arousal-excitement-orgasm). Newer Antidepressants had a negative affect on "auto" and couple sexual performance.

Source: Corona G., et al., "Selective serotonin reuptake inhibitor-induced sexual dysfunction," Journal of Sexual Medicine, May 2009.

 

Drug Study, April 01, 2009

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Diabetes,

Summary: The American Journal of Psychiatry published a study to assess the risk of diabetes associated with Antidepressant treatment and to examine whether the risk is influenced by treatment duration or daily dose. The authors concluded that long-term use of Antidepressants in at least moderate daily doses was associated with an increased risk of diabetes. This association was observed for both tricyclic Antidepressants and selective serotonin reuptake inhibitors.

Source: Andersohn F, "Long-Term Use of Antidepressants for Depressive Disorders and the Risk of Diabetes Mellitus," American Journal of Psychiatry, April 1, 2009.

 

Drug Study, April 01, 2009

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Weight Gain, Obesity,

Summary: The journal Psychotherapy & Psychosomatics published a study that showed treatment with Antidepressants may be associated with increased risk of obesity.

Source: Scott B. Patten, et al.., "Major Depression, Antidepressant Medication and the Risk of Obesity," Psychotherapy & Psychosomatics journal, Vol. 78, No. 3, April 2009.

 

Drug Study, March 17, 2009

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Heart Problems, Cardiac Events,

Summary: The Journal of the American College of Cardiology published a study that stated, "Women who use Antidepressants appear to be at heightened risk for sudden cardiac death, although the exact nature of the link remains unclear, researchers say." The research team found a link between depression and heart risk; however, sudden cardiac death was associated more strongly with the use of Antidepressant drugs than with symptoms of depression.

Source: "Antidepressant Use Tied to Cardiac Death in Women," U.S. News & World Report, March 2009.

 

Drug Warning, March 10, 2009

Germany

Drug Class: Antidepressant,

Generic Name: Amitriptyline,

Brand Name: Elavil, Endep, Vanatrip,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The German Drug Regulatory Agency (BfArM) issued an official notice to pharmaceutical companies that the approval for all newer Antidepressants on the market has been changed. BfArM now requires the package information leaflets for newer Antidepressants to include information on the increased risk of suicidal behavior in adults under 25 years.

Source: "Abwehr von Gefahren durch Arzneimittel, Stufe II - Antidepressiva: Einheitliche Warnhinweise zum erhöhten Risiko für suizidales Verhalten bei jungen Erwachsenen," Bundesinstitut fuer Arzneimittel und Medizinprodukte, February 15, 2008.

 

Drug Warning, March 05, 2009

Ireland

Drug Class: Antidepressant,

Generic Name: Atomoxetine,

Brand Name: Strattera,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: Irish Medicines Board reissued the following safety information to healthcare professionals about Atomoxetine (Strattera) in lieu of recent concerns about its increased risk of suicidal thoughts and behavior associated with its use. It reminds Healthcare professionals that when Atomoxetine is used, patients should be monitored for signs of depression and/or suicidal thoughts/behavior.

Source: "Medicines for the Management of ADHD (I) Atomoxetine (Strattera)," Irish Medicines Board, March 2009.

 

Drug Warning, March 01, 2009

United Kingdom

Drug Class: Antidepressant,

Generic Name: Atomoxetine,

Brand Name: Strattera,

Age: Children (under 18)

Side Effects: Mania, Psychosis,

Summary: Medicines and Healthcare products Regulatory Agency (UK) published in their Drug Safety Update newsletter new information about Atomoxetine (Strattera). They warned that Atomoxetine is associated with treatment-emergent psychotic or manic symptoms in children without a history of such disorders.

Source: Medicines and Healthcare products Regulatory Agency, Drug Safety Update newsletter, Vol. 2, March 8, 2009.

 

Drug Study, February 23, 2009

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: High Blood Pressure,

Summary: The Journal of Hypertension published a study that compared blood pressure levels between subjects with clinical anxiety and depressive disorders with healthy subjects. The study found that the use of certain Antidepressants was associated with hypertension (high blood pressure).

Source: Licht, CM, et al., "Depression Is Associated With Decreased Blood Pressure, but Antidepressant Use Increases the Risk for Hypertension," The Journal of Hypertension, February 23, 2009.

 

Drug Study, February 06, 2009

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over), Children (under 18)

Side Effects: Infant Withdrawal Symptoms,

Summary: A study published in the Archives of Pediatrics and Adolescent Medicine determined that nearly one-third of newborn infants whose mothers took newer Antidepressants during pregnancy experienced withdrawal symptoms that included high-pitched crying, tremors and disturbed sleep.

Source: Rachel Levinson-Castiel, MD, et al., "Neonatal Abstinence Syndrome After In Utero Exposure to Selective Serotonin Reuptake Inhibitors in Term Infants," Archives of Pediatrics and Adolescent Medicine, Vol. 160, February 2006.

 

Drug Study, February 01, 2009

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Abnormal Bleeding,

Summary: The Journal of Clinical Psychopharmacology published a study that assessed the risk of any bleeding abnormalities, including the risk of gastrointestinal bleeding, associated with Antidepressant exposure. The authors concluded that Antidepressants were associated with a modestly increased risk of gastrointestinal bleeding abnormalities.

Source: Barbui C, Andretta M, et al., "Antidepressant drug prescription and risk of abnormal bleeding: a case-control study," Journal of Clinical Psychopharmacology, Vol. 29, No.1, February 2009.

 

Drug Study, February 01, 2009

United States

Drug Class: Antidepressant, Antipsychotic, Antianxiety,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Cognitive Decline, Cognitive Impairment,

Summary: The Journal of the American Geriatric Society published a study that evaluated whether combined use of multiple central nervous system (CNS - including benzodiazepines, antipsychotics and Antidepressants) drugs over time is associated with cognitive change. The authors concluded that combined use of CNS drugs, especially at higher doses, appears to be associated with cognitive decline in older adults.

Source: Wright R.M., et al., "Effect of central nervous system medication use on decline in cognition in community-dwelling older adults: findings from the Health, Aging And Body Composition Study," The Journal of the American Geriatric Society, Vol. 57, No. 2,

 

Drug Study, January 01, 2009

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Risk of Falls, Risk of Fractures, Falls,

Summary: The Annals of Pharmacotherapy published a study that evaluated previous studies that associated the risk of fracture during Antidepressant therapy. After reviewing thirteen clinical studies, the authors concluded that there might be a correlation with SSRI or tricyclic Antidepressant use and risk of fracture.

Source: Ginzburg R. and Rosero E, "Risk of Fractures with Selective Serotonin-Reuptake Inhibitors or Tricyclic Antidepressants," The Annals of Pharmacotherepy, January 2009.

 

Drug Warning, November 20, 2008

European Union

Drug Class: Antidepressant,

Generic Name: Atomoxetine,

Brand Name: Strattera,

Age: Children (under 18)

Side Effects: Hallucinations, Delusional Thinking, Sensory Disturbances, Mania, Psychosis, Agitation, Irritability,

Summary: Eli Lilly included in their Strattera label in Europe warnings that Strattera causes "hallucinations, delusional thinking, mania or agitation in children and adolescents without a prior history of psychotic illness or mania..."

Source: "Official warnings issued: The ADHD drug Strattera CAUSES psychosis, hallucinations, mania and agitation" TransWorldNews, November 20, 2008.

 

Drug Warning, October 01, 2008

Australia

Drug Class: Antidepressant,

Generic Name: Carbamazepine, Paroxetine, Venlafaxine, Sertraline,

Brand Name: Carbatrol, Epitol, Equetro, Tegretol, Paxil, Seroxat, Effexor, Zoloft,

Age: Adults (18 and over)

Side Effects: Blood Disorders,

Summary: The Australian Adverse Drug Reaction Bulletin published a report called "Drug-induced Hyponatraemia" (low sodium levels in the blood). One of the main drugs suspected as causing hyponatraemia adverse reactions are Antidepressants. The Bulletin warned that there have been many reports of this side effect to the Australian Therapeutic Goods Administration.

Source: "Drug-induced Hyponatraemia," Australian Adverse Drug Reaction Bulletin, Vol. 27, No. 5, October 2008.

 

Drug Warning, September 19, 2008

Ireland

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The Irish Medicines Board issued a "Notice Information: Human Medicines - Publication" on Antidepressants, that addresses suicidal behavior associated with use of Antidepressants, in relation to children and adolescents, following a comprehensive review of available clinical trial data undertaken by the European Union (EU) and US levels to further assess the risk of suicidality. "As a result of this review, it was agreed at EU level that the product information for all Antidepressants should be further updated to more fully reflect the current evidence regarding the potential risk of suicidal behavior with Antidepressants..."

Source: Irish Medicines Board, "Antidepressants -- Update on suicidal thoughts and behaviour," Notice Information: Human Medicines - Publication, September 19, 2008.

 

Drug Warning, September 01, 2008

United States

Drug Class: Antidepressant,

Generic Name: Citalopram, Escitalopram,

Brand Name: Celexa, Lexapro,

Age: Adults (18 and over)

Side Effects: Abnormal Bleeding, Blood Disorders,

Summary: FDA's MedWatch modified the precautions of Celexa and Lexapro (Antidepressants) to include information on risks of Hyponatremia (low blood sodium levels) and abnormal bleeding especially when combined with other drugs such as aspirin.

Source: "Detailed View: Safety Labeling Changes" FDA Center for Drug Evaluation and Research, September 2008.

 

Drug Study, September 01, 2008

United Kingdom

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Depression, Anxiety, Sleep Problems , Insomnia,

Summary: A study presented at the 21st European College of Neuropsychopharmacology Congress identified a group of patients in primary care who were on long-term treatment with selective serotonin reuptake inhibitors. They reported that a substantial proportion of patients displayed remaining depressive and anxiety symptoms as well as sleep problems in spite of their treatment.

Source: Judith Moser, "Long-Term Antiderpessant Treatment Without Active Management Hardly Increases Remission: Presented at ECNC," Doctors-Guide, September 1, 2008.

 

Drug Study, August 01, 2008

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Risk of Falls, Risk of Fractures, Falls,

Summary: The Journal of Clinical Psychopharmacology published a study on the association between Antidepressants and the risk of non-spinal fractures in elderly. The authors concluded that users of Antidepressants have a significantly increased risk of non-spinal fractures.

Source: Ziere G, Dieleman JP, et al., "Selective serotonin reuptake inhibiting Antidepressants are associated with an increased risk of nonvertebral fractures," The Journal of Clinical Psychopharmacology, Vol. 28, No. 4, pp. 411-417, August 2008.

 

Drug Study, July 15, 2008

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Neuroleptic Malignant Syndrome,

Summary: Annals of Pharmacotherapy published a study on Neuroleptic Malignant Syndrome (NMS)* associated with the use of newer Antidepressants and second-generation antipsychotics. The author concluded that the "use of SSRIs [newer Antidepressants] may be associated with an increased risk of NMS development in those receiving second-generation antipsychotics." *Neuroleptic Malignant Syndrome: a life-threatening neurological disorder most often caused by an adverse reaction to antipsychotic drugs. High fever, sweating, rigidity, blood pressure changes, confusion, coma, and sometimes death are caused.

Source: Stevens DL, "Association Between Selective Serotonin-Reuptake Inhibitors, Second-Generation Antipsychotics, and Neuroleptic Malignant Syndrome (September)," Annals of Pharmacotherapy, July 15, 2008.

 

Drug Warning, July 01, 2008

Canada

Drug Class: Antidepressant,

Generic Name: Atomoxetine,

Brand Name: Strattera,

Age: Children (under 18)

Side Effects: Self-Harm, Suicide Risk, Suicide Attempts, Suicide,

Summary: Health Canada's Adverse Drug Reaction Newsletter issued a report entitled "Atomoxetine (Strattera) and Suicidal Behaviour: Update." This report reviewed the recent activities involved with warning the public about the risk of self-harm and the necessity of monitoring suicidal behavior while on this drug. Further, "Health care professionals should remind patients, family members and caregivers to monitor moods, behaviors, thoughts and feelings when ADHD medications are used."

Source: "Canadian Adverse Reaction Newsletter," Health Canada, Vol. 18, Iss. 3, July 2008.

 

Drug Study, July 01, 2008

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Upper gastrointestinal bleeding,

Summary: The Archives of General Psychiatry published a study that investigated the risks of newer Antidepressants, reported to increase risk of upper gastrointestinal tract bleeding. The authors concluded: "Antidepressants ... increase the risk of upper gastrointestinal tract bleeding."

Source: Francisco J. de Abajo, MD, MPH, PhD, et al., "Risk of Upper Gastrointestinal Tract Bleeding Associated With Selective Serotonin Reuptake Inhibitors and Venlafaxine Therapy," The Archives of General Psychiatry, Vol. 65, No. 7, July 2008.

 

Drug Study, July 01, 2008

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Tumors in Lymph Nodes,

Summary: The journal Epidemiology came out with a study that looked at the increased risk of non-Hodgkin lymphoma (any of a large group of cancers of the lymph nodes) that had been reported among long-term users of tricyclic Antidepressants. Based on their research, they've concluded that "an increased risk of non-Hodgkin lymphoma specifically among long-term users of tricyclic Antidepressant medications."

Source: Dalton, Susanne Oksbjera, et al., "Tricyclic Antidepressants and Non-Hodgkin Lymphoma [any of a large group of cancers of the immune system]," Epidemiology, Vol. 19, No. 4, pp. 546-549, July 2008.

 

Drug Study, June 30, 2008

Canada

Drug Class: Antidepressant,

Generic Name: Amitriptyline, Imipramine, Doxepin, Fluvoxamine, Paroxetine , Fluoxetine, Bupropion, Mirtazapine, Nefazodone , Reboxetine,

Brand Name: Elavil, Endep, Vanatrip, Tofranil, Adapin, Silenor, Sinequan, Luvox, Paxil, Seroxat, Prozac, Wellbutrin, Zyban, Remeron, Serzone, Edronax, Vestra,

Age: Adults (18 and over)

Side Effects: Heart Problems, Cardiac Events,

Summary: BioPsychoSocial Medicine published a study that sought "to provide an overview of the literature examining the effects of pharmacologic and physical treatments for depression on Heart Rate Variability [HRV] in medically otherwise well patients with MDD [Major Depressive Disorder]." After looking through the literature, the authors concluded, "The use of TCAs [Tricyclic Antidepressants] in depression leads to changes in HRV that are associated with increased risk of mortality."

Source: Louis T van Zyl, et al., "Effects of Antidepressant treatment on heart rate variability [HRV] in major depression: A quantitative review," BioPsychoSocial Medicine, Vol 2, No. 12, June 30 2008.

 

Drug Study, June 01, 2008

United Kingdom

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Risk of Falls, Risk of Fractures, Falls,

Summary: Public Library of Science Medicine published a study that sought to "investigate associations between depressive symptoms, medication use, falls and fall-related injury." The authors concluded that, "Antidepressant use... was strongly associated with falls regardless of presence of depressive symptoms."

Source: Ngaire Kerse, et al., "Falls, Depression and Antidepressants in Later Life: A Large Primary Care Appraisal," Public Library of Science, Vol. 3, Is. 6, June 2008.

 

Drug Warning, April 01, 2008

United States

Drug Class: Antidepressant,

Generic Name: Fluvoxamine,

Brand Name: Luvox,

Age: Adults (18 and over)

Side Effects: Abnormal Bleeding,

Summary: FDA's MedWatch added the following information to the Luvox safety label: newer Antidepressants, including Luvox Tablets, may increase the risk of bleeding events. Simultaneous use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk.

Source: "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - April 2008," FDA MedWatch, April 2008.

 

Drug Warning, March 01, 2008

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Adults (18 and over)

Side Effects: Abnormal Bleeding, Blood Disorders,

Summary: FDA's MedWatch added the following information to the Prozac safety label: Abnormal Bleeding, Hyponatremia (not enough sodium in the body fluids outside the cells), may result; certain drug interactions with drugs such as, NSAIDs (non-steroid anti-inflammatory drugs), aspirin, and warfarin (an anticoagulant), and precautions with geriatric use.

Source: "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - March 2008," FDA MedWatch, March 2008.

 

Drug Study, February 28, 2008

United States

Drug Class: Antidepressant,

Generic Name: Amitriptyline,

Brand Name: Elavil, Endep, Vanatrip,

Age: Adults (18 and over)

Side Effects: Blood Clots,

Summary: Pharmacotherapy published a study that concludes: "Current exposure to amitriptyline [Antidepressant], particularly at high doses, was associated with an increased risk of idiopathic [of unknown cause] venous thromboembolism [the formation of blood clots within a vein]."

Source: Jick SS, Li L., "Antidepressant drug use and risk of venous thromboembolism," Pharmacotherapy, Vol. 28, No. 2, February 2008.

 

Drug Warning, February 05, 2008

United Kingdom

Drug Class: Antidepressant,

Generic Name: Bupropion, Citalopram, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine, Mirtazapine, Nefazodone, Paroxetine, Sertraline, Venlafaxine,

Brand Name: Aplenzin, Wellbutrin, Zyban, Celexa, Cymbalta, Lexapro, Prozac, Luvox, Remeron, Serzone, Paxil, Seroxat, Zoloft, Effexor,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: UK's Medicines and Healthcare products Regulatory Agency ordered drug companies to update the warnings on Antidepressants showing they cause suicidal thoughts and behavior.

Source: "Implementation of warnings on suicidal thought and behaviour in Antidepressants," Medicines and Healthcare Products Regulatory Agency, February 5, 2008.

 

Drug Warning, February 01, 2008

United States

Drug Class: Antidepressant,

Generic Name: Venlafaxine,

Brand Name: Effexor,

Age: Adults (18 and over)

Side Effects: Abnormal Bleeding,

Summary: MedWatch, the FDA's safety information and adverse event reporting program, added information to the Effexor safety label to include risks of abnormal bleeding, and that extra caution should be taken when using this drug with NSAIDs (non-steroid anti-inflammatory drugs), aspirin, and warfarin (an anticoagulant).

Source: "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - February 2008," FDA MedWatch, February 2008.

 

Drug Warning, February 01, 2008

United States

Drug Class: Antidepressant,

Generic Name: Selegiline,

Brand Name: Emsam,

Age: Children (under 18), Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: FDA's MedWatch added to the Emsam (Antidepressant patch) safety label warnings of the potential for clinical worsening and suicide risk related to the use of this drug. Furthermore, due to the limited data, Emsam at any dose should not be used in children under the age of 12 years even when administered with dietary modifications. Emsam is not approved for use in pediatric patients.

Source: "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - February 2008," The FDA Safety Information and Adverse Event Reporting Program, February 2008.

 

Drug Study, January 22, 2008

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Heart Problems, Cardiac Events,

Summary: The Annals of Pharmacotherapy published a study that found a 24% increased risk of a Cerebrovascular Events (stroke) in patients with current exposure to selective serotonin-reuptake inhibitors, and 34% increased risk for current exposure to tricyclic Antidepressants, and 43% increased risk for current exposure to other Antidepressants.

Source: Yan Chen, MB MPH PhD, et al.., "Risk of Cerebrovascular Events Associated with Antidepressant Use in Patients with Depression: A Population-Based, Nested Case-Control Study," The Annals of Pharmacotherapy, Vol. 42, No. 2, January 22, 2008.

 

Drug Warning, January 01, 2008

European Union

Drug Class: Antidepressant,

Generic Name: Bupropion, Citalopram, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine, Mirtazapine, Nefazodone, Paroxetine, Sertraline, Venlafaxine,

Brand Name: Wellbutrin, Celexa, Cymbalta, Lexapro, Prozac, Luvox, Savella, Remeron, Paxil, Seroxat, Zoloft, Effexor, Zyban,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The Pharmacovigilance Working Party (a party that provides advice on the safety of medicinal products and on the investigation of adverse reactions associated with medicinal products authorized in the European Union) recommended an update to product labeling and all Antidepressants patient information leaflets to include information on the increased risk of suicide for children to young adults.

Source: "Antidepressants and suicidal thoughts and behaviour," Pharmacovigilance Working Party, January 2006.

 

Drug Study, October 24, 2007

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: A study presented at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry by Sheila Marcus, MD found that babies born to mothers who take Antidepressant medication during pregnancy have high levels of cortisol (primary stress hormone) in cord-blood at birth, and their mothers are more likely to experience delivery complications.

Source: Sheila Marcus, M.D., "Antidepressant Medication and Depression Status: Impact on Neonatal Outcomes," presented at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry, October 24, 2007.

 

Drug Study, October 08, 2007

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine , Fluoxetine, Sertraline,

Brand Name: Paxil, Seroxat, Prozac, Zoloft,

Age: Adults (18 and over)

Side Effects: Upper Gastrointestinal Bleeding,

Summary: Alimentary Pharmacology & Therapeutics published a study that found that newer Antidepressants may double the risk of gastrointestinal (GI) bleeding. They found patients taking newer Antidepressants were nearly twice as likely to develop upper GI bleeding than patients not taking the drugs. When the patients also took "non-steroidal anti-inflammatory drugs", such as Ibuprofen, the risk of upper gastrointestinal bleeding was six times higher than in patients taking neither medication.

Source: "Study: Antidepressants Double Stomach Bleeding Risk, Mixing with painkillers Increase Six Times," FoxNews.com, October 9, 2007.

 

Drug Study, August 01, 2007

United States

Drug Class: Antidepressant,

Generic Name: Sertraline, Fluoxetine, Citalopram, Paroxetine, Venlafaxine, Nortriptyline, Escitalopram, Nefazodone , Bupropion,

Brand Name: Zoloft, Prozac, Celexa, Paxil, Seroxat, Effexor, Avetyl, Pamelor, Serzone, Wellbutrin, Zyban,

Age: Adults (18 and over), Children (under 18)

Side Effects: Premature Birth,

Summary: The American Journal of Psychiatry published a study which found that Antidepressant use, not depression, during pregnancy was associated with premature births.

Source: Rita Suri, M.D, et al.., "Effects of Antenatal Depression and Antidepressant Treatment on Gestational Age at Birth and Rick of Preterm Birth," Am J Psychiatry 2007; 164: 1206-1213.

 

Drug Study, June 28, 2007

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Sertraline, Paroxetine, Citalopram,

Brand Name: Prozac, Zoloft, Paxil, Seroxat, Celexa,

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects,

Summary: A study published in the New England Journal of Medicine found that infants born to women taking commonly prescribed newer Antidepressants during the first trimester of their pregnancies have a slightly higher risk of life-threatening birth defects.

Source: Carol Louik, Sc.D., et al., "First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects," New England Journal of Medicine, Vol. 356, No. 26, June 28, 2007.

 

Drug Study, June 25, 2007

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Lowered Bone Mass, Lowered Bone Mineral Density,

Summary: A study came out in the Archives of Internal Medicine, showing that newer Antidepressants dangerously reduce the bone mineral density (BMD) in elderly men. Low BMD means an increased risk of fracture and weaker bones.

Source: Elizabeth M. Haney, MD, et al.., "Association of Low Bone Mineral Density With Selective Serotonin Reuptake Inhibitor Use by Older Men," Archives of Internal Medicine, Vol. 167, No. 12, June 25, 2007.

 

Drug Study, May 25, 2007

United States

Drug Class: Antidepressant,

Generic Name: Venlafaxine,

Brand Name: Effexor,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide ,

Summary: Psychiatric Times published an article about a study of newer Antidepressants appearing in the bloodstream of "unnatural" deaths recorded by the Virginia Medical Examiner's Office between 1987 through 2003. The study, by Dr. Antony Fernandez and colleagues, found that Antidepressants were discovered in the blood stream of suicide victims significantly more often than in accident or murder victims. The analysis also showed that among the suicides, newer Antidepressants appeared in equal proportion among those who died from poisoning, guns or hanging. MedPage Today notes that the study was published as an abstract and has not yet been published in a peer-reviewed publication.

Source: Neil Osterweil, "APA: SSRIs More Likely in Suicides Then in Other Young Deaths," Psychiatric times, 25 May, 2007.

 

Drug Warning, May 02, 2007

United States

Drug Class: Antidepressant,

Generic Name: Clomipramine, Amoxapine, Nortriptyline, Citalopram, Duloxetine, Trazodone, Amitriptyline, Venlafaxine, Selegiline, Perphenazine and Amitriptyline, Fluvoxamine, Escitalopram, Chlordiazepoxide and Amitriptyline, Maprotiline, Isocarboxazid, Phenelzine, Nefazodone, Desipramine, Nortriptyline, Tranylcypromine, Paroxetine, Fluoxetine, Mirtazapine, Quetiapine, Doxepin, Trimipramine, Fluoxetine and Olanzapine, Imipramine, Protriptyline, Bupropion, Sertraline,

Brand Name: Anafranil, Asendin, Aventyl, Celexa, Cymbalta, Desyrel, Elavil, Effexor, Emsam, Etrafon, Lexapro, Limbitrol, Ludiomil, Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Seroxat, Pexeva, Prozac, Remeron, Sarafem, Seroquel, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-Pm, Triavil, Vivactil, Wellbutrin, Zoloft, Zyban, Pertofrane,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The FDA officially extended the age group covered in the October 15, 2004 black box warning regarding Antidepressants causing suicidal tendencies, to include 18 to 24 year-olds.

Source: "FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications," FDA News, May 2, 2007.

 

Drug Study, April 27, 2007

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Parkinson's disease,

Summary: A study presented at the American Academy of Neurology's 59th Annual Meeting found that people who are taking Antidepressant drugs are more likely to develop Parkinson's disease (a degenerative disease of the brain that often impairs motor skills, speech, and other functions) than people who are not taking the medications. Researchers said that in the year before their Parkinson's disease was diagnosed, people who were taking Antidepressants were nearly twice as likely to develop Parkinson's disease as those who were not taking Antidepressants.

Source: Angela Babb and Robin Stinnett, "Depression May Be Early Sign of Parkinson's Disease," American Academy of Neurology Press Release, April 27, 2007.

 

Drug Warning, February 21, 2007

United States

Drug Class: Antidepressant, Stimulant,

Generic Name: Amphetamine and Dextroamphetamine, Methylphenidate, Methamphetamine, Dextroamphetamine, Dexmethylphenidate, Atomoxetine,

Brand Name: Adderall, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Metadate CD, Methylin, Ritalin, Ritalin SR, Ritalin LA, Strattera,

Age: Adults (18 and over), Children (under 18)

Side Effects: Mania, Psychosis, Stroke, Cerebrovascular Events, Heart Problems, Cardiac Events,

Summary: The FDA directed ADHD drug manufacturers to distribute "patient friendly" guides to consumers warning about serious psychiatric and cardiovascular problems, including stroke, heart attack, sudden death and psychotic reactions caused by ADHD drugs.

Source: "FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events," FDA News, February 21, 2007.

 

Drug Study, January 22, 2007

United States

Drug Class: Antidepressant,

Generic Name: Citalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline,

Brand Name: Celexa, Prozac, Luvox, Paxil, Seroxat, Zoloft,

Age: Adults (18 and over)

Side Effects: Risk of Falls, Risk of Fractures, Falls,

Summary: Archives of Internal Medicine published a study that reviewed the relationship between regular use of newer Antidepressants and fractures. The study examined a group of Canadians that were aged 50 or older and concluded that daily newer Antidepressant use in adults 50 years and older was associated with a 2-fold increased risk of bone fractures because of falls.

Source: J. Brent Richards, "Effect of Selective Serotonin Reuptake Inhibitors on the Risk of Fracture," Archives of Internal Medicine, Vol 167, January 22, 2007.

 

Drug Study, December 29, 2006

Canada

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects,

Summary: A new study published in Birth Defects Research Part B, on Developmental and Reproductive Toxicology on Paxil, found that Paxil and other Antidepressant use in pregnant women increased the possibility that their babies would be born with birth defects.

Source: Roman Bystrianyk, "Paroxetine (Paxil or Paxil CR) can more than triple major cardiac birth Defects," Health Sentinel, December 29, 2006 citing: Birth Defects Research Part B: Developmental and Reproductive Toxicology, December 2006.

 

Drug Study, November 01, 2006

Denmark

Drug Class: Antidepressant,

Generic Name: Citalopram, Sertraline, Fluvoxamine, Fluoxetine, Paroxetine,

Brand Name: Celexa, Zoloft, Luvox, Prozac, Paxil, Seroxat,

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects,

Summary: An Epidemiology study found that pregnant women who took newer Antidepressants were more likely to have babies with birth defects than mothers who didn't take these drugs.

Source: Wogelius, Pia, Norgaard, Mette, Gislum, Mette, Pedersen, Lars, Munk, Estrid, et al., "Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations," Epidemiology, Vol. 17, No. 6, November 2006.

 

Drug Study, November 01, 2006

United States

Drug Class: Antidepressant,

Generic Name: Amitriptyline, Doxepin, Maprotiline, Trimipramine, Citalopram, Paroxetine, Mirtazapine, Venlafaxine,

Brand Name: Elavil, Endep, Vanatrip, Adapin, Silenor, Sinequan, Ludiomil, Surmontil, Celexa, Paxil, Seroxat, Remeron, Effexor,

Age: Adults (18 and over)

Side Effects: Impaired Driving Ability,

Summary: The Journal of Clinical Psychiatry reported that about seven of every ten people who take Antidepressants have impaired driving ability due to the drugs. The study showed that driving on these drugs make the roads more dangerous, slowing down reaction times and leaving users drowsy. About 190 million Antidepressant prescriptions were written in the U.S. in 2005 and about 16% of people who take the drugs had severe motor impairments after taking them.

Source: Alexander Brunnauer, Ph.D., et al., "Antidepressants and Driving Ability: Results from a Clinical Study," Journal of Clinical Psychiatry, Vol. 67, No. 11, November 2006.

 

Drug Study, November 01, 2006

United Kingdom

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Sertraline, Citalopram, Paroxetine, Venlafaxine, Mirtazapine,

Brand Name: Prozac, Zoloft, Celexa, Paxil, Seroxat, Effexor, Remeron,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The British Journal of Psychiatry published a study that found five percent of children taking Antidepressants were involved in self-harm or suicidal events, compared with three percent of those taking dummy pills.

Source: Bernadka Dubicka MD, Sarah Hadley MSc and Christopher Roberts PhD, "Suicidal behaviour in youths with depression treated with new-generation Antidepressants - Meta-analysis," British Journal Of Psychiatry, Vol. 189, November 2006.

 

Drug Warning, October 18, 2006

Australia

Drug Class: Antidepressant, Stimulant,

Generic Name: Atomoxetine, Methylphenidate, Dexamphetamine,

Brand Name: Strattera, Ritalin,

Age: Children (under 18)

Side Effects: Headaches, Nausea, Vomiting, Depression, Sleepiness, Drowsiness, Fatigue, Agitation, Irritability, Insomnia, Disturbed Sleep, Heart Problems, Cardiac Events, Abnormally Tight Muscles,

Summary: The Australian Therapeutic Goods Administration (TGA) ordered manufacturers of Ritalin, Strattera and dexamphetamine to add stronger warnings to their information packaging after receiving 200 complaints about the drugs. The TGA had received 123 reports of adverse reactions involving Ritalin, including complaints that it caused headache, nausea, anorexia, somnolence (sleepiness) and depression; 23 reports about atomoxetine (Strattera), including aggression, and 60 reports about dexamphetamine, including seven of agitation, five of tachycardia (rapid heartbeat) and four reports each of hypertonia (abnormally tight muscles), hyperkinesia (muscle spasm) and insomnia.

Source: "ADHD drug risks for kids", The Australian, Matthew Franklin, October 18, 2006.

 

Drug Warning, October 17, 2006

United States

Drug Class: Antidepressant,

Generic Name: Venlafaxine,

Brand Name: Effexor,

Age: Adults (18 and over)

Side Effects: Dependence, Addiction, Medication Abuse,

Summary: Drug company Wyeth, in a letter to doctors released by the FDA, warned them to limit the number of Effexor (venlafaxine) pills they prescribe patients to reduce the risk of overdose. There were reports of deaths and serious injuries in patients who overdosed on Effexor predominantly when taken with alcohol and/or other drugs. To limit the risk of overdose, doctors should prescribe the "smallest quantity of capsules consistent with good patient management," Wyeth wrote.

Source: Joseph Camardo, MD, "Dear Health Care Provider," Wyeth, October 17, 2006.

 

Drug Study, October 01, 2006

United States

Drug Class: Antidepressant,

Generic Name: Imipramine, Nortriptyline, Desmethylimipramine, Bupropion, Venlafaxine, Sertraline, Citalopram,

Brand Name: Tofranil, Aventyl, Pamelor, Wellbutrin, Zyban, Effexor, Zoloft, Celexa,

Age: Adults (18 and over)

Side Effects: Sperm Count Decreased, Fertility Potential Decreased , Sexual Dysfunction,

Summary: A study presented at the American Society for Reproductive Medicine conference on two men who, while on Antidepressants, had their sperm counts drop dramatically to almost zero. However, recovered to healthy levels when the drugs were suspended.

Source: Cigdem Tanrikut and Peter N. Schlegel, "Antidepressant-Associated Changes in Semen Parameters," Urology, Vol. 69, No. 1, 2007.

 

Drug Study, September 01, 2006

United Kingdom

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Aggression, Violence, Hostility,

Summary: A study published in Public Library of Science Medicine determined that newer Antidepressants could increase the risk of violence in people taking them. They looked specifically at GlaxoSmithKline's Paxil and concluded the drug raises the risk of severe violence in some people.

Source: Healy M.D., David, Herxheimer, Andrew, Menkes, David B., "Antidepressants and Violence: Problems at the Interface of Medicine and Law," Public Library of Science Medicine, September 2006.

 

Drug Study, August 01, 2006

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Children (under 18), Adults (18 and over)

Side Effects: Stunted Growth, Respiratory Problems,

Summary: A study published in the Archives of General Psychiatry found that women who took newer Antidepressants during pregnancy were at an increased risk of having a low birth weight baby with respiratory problems.

Source: Tim F. Oberlander, MD, et al., "Neonatal Outcomes After Prenatal Exposure to Selective Serotonin Reuptake Inhibitor Antidepressants and Maternal Depression Using Population-Based Linked Health Data," Archives of General Psychiatry, August 2006.

 

Drug Study, August 01, 2006

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine , Sertraline, Fluoxetine,

Brand Name: Paxil, Seroxat, Zoloft, Prozac,

Age: Children (under 18)

Side Effects: Suicide risk, Suicide Attempts, Suicide,

Summary: The Archives of General Psychiatry published a study which found that children taking newer Antidepressants were 1.52 times more likely to attempt suicide and 15 times more likely to succeed in the attempt than those not taking the drugs.

Source: Mark Olfson, MD, MPH, et al., "Antidepressant Drug Therapy and Suicide in Severely Depressed Children and Adults," The Archives of General Psychiatry, Vol. 63, August 2006.

 

Drug Warning, July 19, 2006

United States

Drug Class: Antidepressant,

Generic Name: Citalopram, Fluvoxamine, Escitalopram, Paroxetine, Fluoxetine, Fluoxetine and Olanzapine, Sertraline, Duloxetine, Venlafaxine,

Brand Name: Celexa, Luvox, Lexapro, Paxil, Seroxat, Prozac, Symbyax, Zoloft, Cymbalta, Effexor,

Age: Adults (18 and over)

Side Effects: Serotonin Syndrome,

Summary: The FDA issued a Public Health Advisory regarding the combination of certain migraine medications and certain types of Antidepressants. The combination of these drugs can cause a life-threatening condition called serotonin syndrome (which occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea). The migraine medications (Amerge, Axert, Frova, Imitrex, Maxalt, Maxalt-MLT, Relpax, Zomig, Zomig-ZMT) should not be combined with any of these newer Antidepressants: Celexa, Luvox, Lexapro, Paxil, Prozac, Symbyax, Zoloft, Cymbalta, Effexor.

Source: "FDA Health Advisory - Combined use of 5-Hydroxytryptamine Receptor Agonists..., Selective Serotonin Reuptake Inhibitors...or Selective Serotonin/Norepinephrine Reuptake Inhibitors...May Result in Life-threatening Serotonin Syndrome," FDA, July 19, 2006.

 

Drug Warning, July 19, 2006

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine, Fluoxetine, Sertraline, Fluoxetine and Olanzapine, Fluvoxamine, Duloxetine, Venlafaxine,

Brand Name: Paxil, Seroxat, Prozac, Zoloft, Symbyax, Luvox, Cymbalta, Effexor,

Age: Adults (18 and over), Children (under 18)

Side Effects: Blood Pressure Changes, Birth Defects,

Summary: The FDA warned of the risk of a fatal lung condition in newborns whose mothers took newer Antidepressants during pregnancy. The agency added it was seeking more information about persistent pulmonary hypertension (heart and lung disorder) in newborns from the drugs. It asked drug makers to list the potential risk on their drug labels.

Source: Susan Heavey, "U.S. FDA warns of new Antidepressant risks," Reuters, July 19, 2006.

 

Drug Study, July 12, 2006

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Diabetes,

Summary: The American Diabetes Association's 66th Annual Scientific Sessions issued a study that determined the use of Antidepressant drugs was associated with a significantly increased risk of developing Type 2 diabetes in people who were already at risk of having the disease. While it was known that antipsychotics could increase the risk of diabetes, this was the first study to link Antidepressant drugs to diabetes.

Source: "Diabetes Complications, Antidepressants are associated with increased risk of diabetes in pre-diabetics," Biotech Week, July 12, 2006.

 

Drug Warning, June 14, 2006

Japan

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: Japan's Health Ministry ordered GlaxoSmithKline to change its package insert for Paxil to add the warning that the drug can cause suicidal behavior in young adults and that patients should be observed carefully when it is prescribed to them. According to the Health Ministry, clinical tests conducted in foreign countries showed that 11 out of 3,455 people (0.32%) who were taking Paxil attempted suicide. On the other hand, only 1 of 1,978 people (0.05%) who were taking placebo attempted suicide. Suicidal actions were often shown amongst 18-30 year-olds.

Source: "Danger of increasing attempt of suicide: The Health Ministry calls for attention on Paxil," Shimotsuke Newspaper, June 14, 2006.

 

Drug Warning, June 05, 2006

Australia

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Sertraline, Paroxetine, Escitalopram, Fluvoxamine,

Brand Name: Prozac, Zoloft, Lexapro, Luvox, Aropax,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide, Tourette's Syndrome, Deafness, Motor Impairment, Paralysis, Hallucinations, Delusional Thinking, Sensory Disturbances, Self-Harm, Convulsions, Seizures, Muscle Spasms, Death, Sudden Death,

Summary: The Australian Therapeutic Goods Administration drug adverse reaction database showed there had been 827 notified adverse reactions report-in 380 separate cases-for Antidepressant use among under 10 year olds. Apart from deaths, these included convulsions, self-harm, muscle spasms, tremors, hallucinations, deafness, paralysis and Tourette's syndrome. A further 833 adverse health responses, in 385 cases, had been linked to use by youths aged between 10 and 19 years. The reactions included 3 deaths.

Source: "Drugs driving kids to suicide" Daily Telegraph, June 5, 2006.

 

Drug Warning, May 31, 2006

United Kingdom

Drug Class: Antidepressant,

Generic Name: Venlafaxine,

Brand Name: Effexor,

Age: Adults (18 and over)

Side Effects: Heart Problems, Cardiac Events,

Summary: The Medicines and Healthcare products Regulatory Agency (UK) issued a press release on the drug Effexor (venlafaxine) advising of updated prescribing information showing that people with the risk of heart attack or high blood pressure should not use the drug.

Source: Gordon Duff, "Updated Prescribing Advice for Venlafaxine (Effexor/Effexor XL)," Commission on Human Medicines, May 31, 2006.

 

Drug Warning, May 26, 2006

Canada

Drug Class: Antidepressant, Stimulant,

Generic Name: Amphetamine and Dextroamphetamine, Dextromethylphenidate, Methylphenidate, Dextroamphetamine, Atomoxetine,

Brand Name: Adderall XR, Attenade, Biphentin, Concerta, Dexedrine, Ritalin, Ritalin SR, Strattera,

Age: Adults (18 and over), Children (under 18)

Side Effects: Death, Sudden Death, Blood Pressure Changes, Heart Problems, Cardiac Events, Stroke, Cerebrovascular Events,

Summary: Health Canada issued new warnings of rare heart risks for all drugs prescribed for ADHD, including the risk of sudden death. The public advisory cautioned that the stimulants can increase heart rate and blood pressure and that this can result in "cardiac arrests, strokes or sudden deaths." This warning applies to both adults and children.

Source: "New cautions regarding rare heart-related risks for all ADHD drugs," Health Canada, 2006-35, May 26, 2006.

 

Drug Warning, May 12, 2006

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: GlaxoSmithKline and the U.S. FDA warned doctors that the Antidepressant Paxil increases the risk of suicide in young adults.

Source: "Paxil (paroxetine hydrochloride) Tablets and Oral Suspension" FDA MedWatch, May 12, 2006.

 

Drug Warning, May 09, 2006

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: GlaxoSmithKline issued a change to the Clinical Worsening and Suicide Risk section of the drug literature for Paxil and Paxil CR. GlaxoSmithKline's research showed a higher frequency of suicidal behavior in adults ages 18-24 taking the drug. 2.19% of people showed suicidal behavior who were taking the drug versus only .92% in people taking a placebo.

Source: John E. Kraus, "Important Prescribing Information," GlaxoSmithKline, May 9, 2006.

 

Drug Warning, May 08, 2006

Germany

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: The German Drug Regulatory Agency (BfArM) issued risk information on the newer Antidepressant paroxetine (Paxil), that it increased the risk of cardiac malformation in newborns when the mother took paroxetine during her pregnancy. All German drug manufacturers producing paroxetine drugs were ordered to implement the warning and safety notes on their drug information leaflets.

Source: "Questions and answers on Paroxetine," Risk information of the BfArM, May 8, 2006.

 

Drug Warning, April 25, 2006

Russia

Drug Class: Antidepressant,

Generic Name: Atomoxetine,

Brand Name: Strattera,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: Russia's Ministry of Health and Social Development issued a ban on Strattera (atomoxetine) because of its ability to cause suicidal inclinations.

Source: R. U. Khabriev, "On suspending the state registration of Strattera medication," Ministry of Health and social development of Russia Federation, #970-pr/06, April 25, 2006.

 

Drug Warning, March 10, 2006

Canada

Drug Class: Antidepressant,

Generic Name: Bupropion, Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Mirtazapine, Paroxetine, Sertraline, Venlafaxine,

Brand Name: Wellbutrin, Celexa, Cipralex, Prozac, Luvox, Remeron, Paxil, Seroxat, Zoloft, Effexor, Zyban, Lexapro,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: Health Canada issued an advisory warning for Antidepressant use in pregnant women. Research shows newer Antidepressants may increase risk of a serious lung disorder in newborns. The warning applies to all newer Antidepressants including Wellbutrin, Celexa, Cipralex, Prozac, Luvox, Remeron, Paxil, Zoloft, Effexor, Zyban.

Source: "Newer Antidepressants linked to serious lung disorder in Newborns" Health Canada, March 10, 2005.

 

Drug Study, March 07, 2006

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The Archives of General Psychiatry published a report by the FDA that led to the black box warnings on the Antidepressants showing they could double the risk of suicidal thoughts and actions in children who took them.

Source: "Antidepressants linked to suicide risk in youth," Boston Globe, March 7, 2006.

 

Drug Study, March 01, 2006

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine, Fluoxetine,

Brand Name: Paxil, Seroxat, Prozac,

Age: Children (under 18), Adults (18 and over)

Side Effects: Vomiting, Hyperactivity, Restlessness, Muscle Activity Increased, Agitation,

Summary: The Journal of Child and Adolescent Psychopharmacology published a study on the frequency of common side effects from newer Antidepressants in children, adolescents, and adults. The study found that restlessness, hyperkinesis [abnormal increase in muscle activity], hyperactivity, agitation and vomiting side effects were 2- to 3-fold more prevalent in children than in adolescents, and their rate was lowest in adults. The authors concluded that children are particularly vulnerable to specific side effects from newer Antidepressants.

Source: Daniel J. Safer, M.D. and Julie Magno Zito, Ph.D. "Treatment-Emergent Adverse Events from Selective Serotonin Reuptake Inhibitors by Age Group: Children versus Adolescents," Journal of Child and Adolescent Psychopharmacology, Vol. 16, No. 1/2, 2006.

 

Drug Warning, February 25, 2006

Canada

Drug Class: Antidepressant,

Generic Name: Bupropion, Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Mirtazapine, Paroxetine, Sertraline, Venlafaxine,

Brand Name: Wellbutrin, Zyban, Celexa, Cipralex, Prozac, Luvox, Remeron, Paxil, Seroxat, Zoloft, Effexor, Zyban,

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects,

Summary: Health Canada issued an advisory to the press regarding newer Antidepressants being linked to serious lung disorders in newborns. Health Canada advises that pregnant women taking newer Antidepressants should discuss the situation with their doctor because of the potential risk to the baby.

Source: "Advisory - Newer Antidepressants linked to serious lung disorder in newborns" CNW Group, February 25, 2006.

 

Drug Warning, February 16, 2006

United Kingdom

Drug Class: Antidepressant,

Generic Name: Atomoxetine,

Brand Name: Strattera,

Age: Adults (18 and over)

Side Effects: Heart Problems, Cardiac Events, Convulsions, Seizures, Muscle Spasms, Liver Problems, Liver Failure, Liver Toxicity,

Summary: UK's Department of Health's Commission on Human Medicines issued a warning to health professionals that the Antidepressant Strattera can cause seizures, a potentially dangerous lengthening of time between heartbeats, increase risk of suicidal behavior and can cause severe liver disorders.

Source: Gordon Duff, "Message from Professor G. Duff, Chairman, Commission on Human Medicines," Commission on Human Medicines, CEM/CMO/2006/3, February 16, 2006.

 

Drug Study, February 06, 2006

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Children (under 18), Adults (18 and over)

Side Effects: Infant Withdrawal Symptoms,

Summary: A study published in the Archives of Pediatrics and Adolescent Medicine determined that nearly one-third of newborn infants whose mothers took newer Antidepressants during pregnancy experienced withdrawal symptoms that included high-pitched crying, tremors and disturbed sleep.

Source: Rachel Levinson-Castiel, MD, et al., "Neonatal Abstinence Syndrome After In Utero Exposure to Selective Serotonin Reuptake Inhibitors in Term Infants," Archives of Pediatrics and Adolescent Medicine, Vol. 160, February 2006.

 

Drug Warning, January 01, 2006

Japan

Drug Class: Antidepressant,

Generic Name: Paroxetine, Fluvoxamine, Toledomin,

Brand Name: Paxil, Seroxat, Luvox, Depromel, Milnacipran, Savella,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: Japan's National Health Ministry directed pharmacy companies to revise their Antidepressant drug labeling to warn that they could cause suicidal behaviors.

Source: "Information for revising (drug's) notice for User," The National Health Ministry - Japan, January 13, 2006.

 

Drug Warning, December 16, 2005

Canada

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: Health Canada issued Important Safety Information on Paxil, publishing GlaxoSmithKline's letter to healthcare professionals about the Swedish study that, like GSK, had found heart malformations in newborns of mothers taking Paxil during their first trimester. "Due to the potential for discontinuation symptoms, doctors should inform patients that the drug should not be stopped without first discussing it with their doctor," the letter further states.

Source: "New Safety Information Regarding Paroxetine: Second Large Study Shows an Increased Risk of Cardiac Defects, Over Other Antidepressants, Following First Trimester Exposure to Paroxetine" Health Canada, December 16, 2005.

 

Drug Warning, December 08, 2005

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: The FDA issued a Public Health Advisory that warned physicians about the potential risk to the fetus if they prescribed Paxil to pregnant women in their first trimester. The drug may cause birth defects, including heart malformations.

Source: "FDA Public Health Advisory Paroxetine" Food and Drug Administration (FDA), December 8, 2005.

 

Drug Warning, November 01, 2005

United States

Drug Class: Antidepressant,

Generic Name: Venlafaxine,

Brand Name: Effexor,

Age: Adults (18 and over)

Side Effects: Homicidal Ideation,

Summary: The FDA's Safety Information and Adverse Event Reporting Program reported "homicidal ideation" as an adverse event of Effexor ER (extended release).

Source: "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 2005," FDA MedWatch, November 2005.

 

Drug Warning, October 17, 2005

United States

Drug Class: Antidepressant,

Generic Name: Duloxetine,

Brand Name: Cymbalta,

Age: Adults (18 and over)

Side Effects: Liver Problems, Liver Failure, Liver Toxicity,

Summary: The FDA ordered Eli Lilly & Co. to add a warning to the packaging of its Antidepressant Cymbalta that it can cause liver damage.

Source: "2005 Safety Alerts for drugs, Biologics, Medical Devices, and Dietary Supplements," FDA MedWatch, October 17, 2005.

 

Drug Warning, September 29, 2005

United States

Drug Class: Antidepressant,

Generic Name: Atomoxetine,

Brand Name: Strattera,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The FDA issued a Public Health Advisory entitled, "Suicidal Thinking in Children and Adolescents Being Treated with Strattera (Atomoxetine)." The FDA directed Eli Lilly to revise the labeling of Strattera to include both a boxed warning and additional warning statements that alerted health care providers to an increased risk of suicidal thinking in children and adolescents being treated with the drug.

Source: "Suicidal Thinking in Children and Adolescents Being Treated with Strattera (Atomoxetine)" Center for Drug Evaluation and Research September 2005.

 

Drug Warning, September 29, 2005

Canada

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: GlaxoSmithKline, after discussions with Health Canada, issued a letter to healthcare professionals advising of a change to their prescribing information stating that Paxil is associated with an increase of congenital malformations when used by pregnant women.

Source: "IMPORTANT PRESCRIBING INFORMATION," GlaxoSmithKline, September 2005.

 

Drug Warning, September 29, 2005

United Kingdom

Drug Class: Antidepressant,

Generic Name: Atomoxetine,

Brand Name: Strattera,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a press release that it had begun a review of the risks of Strattera after clinical data indicated an increased risk of suicide in children taking it. MHRA said that updated patient information would warn of this risk.

Source: "Updated warnings on the risk of suicidal thoughts with Strattera" Medicines and Healthcare products Regulatory Agency (MHRA), September 29, 2005.

 

Drug Warning, September 27, 2005

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: The FDA and GlaxoSmithKline issued a warning that according to a recent study the drug company conducted on 3,581 pregnant women taking Paxil or other Antidepressants during their first trimester of pregnancy, there was an increased risk of major congenital [defect at birth] and cardiovascular [heart] malformations at birth for those mothers taking Paxil. The most common defect was malformations between the heart's two main pumping chambers. The GlaxoSmithKline Paxil website also said, "Babies born to mothers who have taken Antidepressants, including newer ones such as Paxil, in the third trimester of pregnancy have reported complications, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, shakiness, irritability or constant crying...There have also been reports of premature births in pregnant women exposed to SSRIs [newer Antidepressants], including Paxil."

Source: Miranda Hitti, "New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants" WebMD, September 27, 2005.

 

Drug Warning, September 26, 2005

Italy

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Children (under 18), Adults (18 and over)

Side Effects: Heart Problems, Cardiac Events,

Summary: A resolution of the Agenzia Italiana del Farmaco (Italian Drug Agency, equivalent to the FDA) ordered a warning label for the packaging of the older Antidepressant drugs, stating that they should not be prescribed for under 18 year olds. Further, it stated these Antidepressants were associated with heart attacks on people of any age.

Source: Agenzia Italiana del Farmaco, Italian Official Gazette #224, September 26, 2005.

 

Drug Warning, September 07, 2005

Australia

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Aropax, Oxetine, Paxtine, Loxamine, Espar, Paroxat CR, Ausrox, Paxil, Seroxat,

Age: Adults (18 and over), Children (under 18)

Side Effects: Birth Defects,

Summary: The Australian Therapeutics Goods Administration issued an information sheet to health professionals warning that use of newer Antidepressants-especially Paxil-in early pregnancy could cause congenital heart abnormalities in newborns. It reported that Danish researchers had determined the association in the first trimester of pregnancy.

Source: "General information concerning use of SSRI Antidepressants in pregnant women" Australian Government, Department of Health and Ageing September 7, 2005.

 

Drug Study, August 22, 2005

United Kingdom

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The journal BMC Medicine published a study that reported, "The data strongly suggests that the use of SSRIs [newer Antidepressants] is connected with an increased intensity and suicide attempts per year." It also found that Paxil (paroxetine) was 7 times more likely to induce suicide in people taking it than those taking placebo.

Source: Ivar Aursnews, et al., "Suicide attempts in clinical trials with paroxetine randomized against placebo," BMC Medicine, August 22, 2005.

 

Drug Warning, August 19, 2005

European Union

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Fluvoxamine, Sertraline, Paroxetine, Citalopram, Escitalopram, Atomoxetine, Duloxetine, Venlafaxine, Mianserin, Milnacipram, Reboxetine, Mirtazapine,

Brand Name: Prozac, Luvox, Zoloft, Paxil, Seroxat, Celexa, Lexapro, Strattera, Cymbalta, Effexor, Savella, Edronax, Vestra, Remeron,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide, Aggression, Violence, Hostility,

Summary: The Commission of the European Communities, representing 25 European countries, endorsed and issued the strongest warning yet against child Antidepressant use as recommended by Europe's Committee for Medicinal Products for Human Use (CHMP). Clinical trials had shown that the drugs caused suicidal behavior including suicide attempts and suicidal ideation, aggression, hostility (predominantly aggression, oppositional behavior and anger) and/or related behavior.

Source: Commission of the European Communities Commission Decision concerning the placement on the market, under Article 21 of the Directive 2001/83/EC of the European Parliament and of the Council, Brussels 19-VIII-2005, C (2205) 3256.

 

Drug Warning, August 04, 2005

Australia

Drug Class: Antidepressant,

Generic Name: Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Venlafaxine,

Brand Name: Celexa, Luvox, Lexapro, Paxil, Seroxat, Zoloft, Effexor,

Age: Adults (18 and over)

Side Effects: Withdrawal Reactions, Suicide Risk, Suicide Attempts, Suicide, Agitation, Irritability, Akathisia, Anxiety, Panic Attacks,

Summary: The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin that reported on a review of newer Antidepressants which found evidence supporting an association between them and "new onset of suicidality" in adults. It usually developed shortly after beginning the drugs or after an increase in dosage that could cause akathisia (body restlessness), agitation, nervousness and anxiety. Similar symptoms could also occur during withdrawal.

Source: "Suicidality with SSRIs: adults and children," The Australian Therapeutic Goods Administration, Adverse Drug Reactions Bulletin, Vol. 24, No. 4, p. 14, August 2005.

 

Drug Warning, July 28, 2005

Canada

Drug Class: Antidepressant, Antipsychotic,

Generic Name: Paroxetine, Pimozide,

Brand Name: Paxil, Seroxat, Orap,

Age: Adults (18 and over)

Side Effects: Heart Problems, Cardiac Events,

Summary: Health Canada issued a release from GlaxoSmithKline (GSK) who, after discussions with Health Canada, issued new safety information regarding the newer Antidepressant Paxil (paroxetine) and Paxil CR. It must not be administered together with Orap (pimozide), an older antipsychotic drug, because it increases the level of Orap in the blood. This may result in arrhythmia (irregular heartbeats) that can sometimes be serious and even life-threatening. GSK sent a letter to health care professionals informing them of this information.

Source: "Subject: Important New Safety Information for the Use of Paxil and Paxil CR in patients taking pimozide," Health Canada, issuing GSK release, July 28, 2005.

 

Drug Warning, June 30, 2005

United States

Drug Class: Antidepressant,

Generic Name: Citalopram, Venlafaxine, Fluvoxamine, Escitalopram, Paroxetine, Fluoxetine, Mirtazapine, Quetiapine,

Brand Name: Celexa, Effexor, Luvox, Lexapro, Paxil, Seroxat, Prozac, Remeron, Sarafem, Seroquel,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The FDA issued a Public Health Advisory entitled "Suicidality in Adults Being Treated with Antidepressant Medications," that stated that several recent scientific publications suggested the possibility of an increased risk of suicidal behavior in adults taking both older and newer Antidepressants. It recommended that physicians monitor adults who took Antidepressants for suicidal tendencies.

Source: "Suicidality in Adults Being Treated with Antidepressant Medications," FDA Public Health Advisory, June 30, 2004.

 

Drug Warning, June 30, 2005

United States

Drug Class: Antidepressant,

Generic Name: Duloxetine,

Brand Name: Cymbalta,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The FDA issued an "Alert for Healthcare Professionals" about the Antidepressant Cymbalta, concluding that suicidal thinking or behavior may increase in pediatric patients treated with any type of Antidepressant, especially early in treatment.

Source: Food and Drug Administration (FDA) "Duloxetine hydrochloride (marketed as Cymbalta) Information" Center for Drug Evaluation and Research June 30, 2005.

 

Drug Warning, April 25, 2005

European Union

Drug Class: Antidepressant,

Generic Name: Atomoxetine, Citalopram, Duloxetine, Escitalopram, Fluoxetine, Fluvoxamine, Mianserin, Milnacepran, Mirtazapine, Paroxetine, Reboxetine, Sertraline, Venlafaxine,

Brand Name: Strattera, Celexa, Cymbalta, Lexapro, Prozac, Luvox, Savella, Remeron, Paxil, Seroxat, Edronax, Vestra, Zoloft, Effexor,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide, Aggression, Violence, Hostility,

Summary: The European Medicines Agency's Committee for Medicinal Products for Human Use, concluded that Prozac-type Antidepressants were associated with increased suicide-related behavior and hostility in young people. The London-based watchdog said it recommended the inclusion of strong warnings across the whole of the European Union to doctors and parents about these risks and that the drugs should not be used in children and adolescents in off label situations.

Source: "EU calls for tougher warnings on Antidepressants for kids" News-Medical.net April 25, 2005.

 

Drug Study, February 19, 2005

United Kingdom

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Sertraline, Paroxetine, Fluvoxamine, Citalopram,

Brand Name: Prozac, Zoloft, Paxil, Seroxat, Luvox, Celexa,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: British Medical Journal published a study that investigated whether newer Antidepressants are associated with an increase suicide risk related to outcomes in adults. Though the researchers said they found lack of evidence that newer Antidepressants increase suicide, that factor could not yet be ruled out. Furthermore, they found evidence of an increased risk of non-fatal self-harm in people taking newer Antidepressants compared to those taking a placebo.

Source: Dean Fergusson, David Healy, et al., "Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials," British Medical Journal, Vol. 330, February 19, 2005.

 

Drug Study, February 05, 2005

United Kingdom

Drug Class: Antidepressant,

Generic Name: Paroxetine, Sertraline, Fluoxetine, Citalopram, Norpramin, Clomipramine,

Brand Name: Paxil, Seroxat, Zoloft, Prozac, Celexa, Desipramine, Anafranil, Norpramin, Pertofrane,

Age: Adults (18 and over), Children (under 18)

Side Effects: Infant Withdrawal Symptoms,

Summary: The Lancet published a study that found that infants whose mothers took Antidepressants while pregnant could suffer withdrawal effects. A study conducted by researchers at the University of British Columbia, concluded, "risks of neonatal convulsions and neonatal withdrawal syndrome seem to be increased with all SSRIs [newer Antidepressants]." Furthermore, that most of these cases were involving the use of paroxetine.

Source: Emilio J. Sanz, et al, "Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis," The Lancet, Vol. 365, February 5, 2005.

 

Drug Study, November 22, 2004

United States

Drug Class: Antidepressant,

Generic Name: Mirtazapine, Maprotiline, Mianserin, Nefazodone, Trazadone, Doxepin, Nortriptyline, Desipramine, Moclobemide, Bupropion, Venlafaxine, Dothiepin, Amitriptyline, Fluvoxamine, Imipramine, Citalopram, Fluoxetine, Sertraline, Clomipramine, Paroxetine,

Brand Name: Remeron, Ludiomil, Serzone, Desyrel, Oleptro, Adapin, Silenor, Sinequan, Aventyl, Pamelor, Manerix, Aurorix, Wellbutrin, Zyban, Effexor, Prothiaden, Dothep, Thaden, Dopress, Elavil, Endep, Vanatrip, Luvox, Tofranil, Celexa, Prozac, Zoloft, Anafranil, Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Abnormal Bleeding,

Summary: Archives of Internal Medicine published a study on the risk of abnormal bleeding associated with Antidepressants. The researchers concluded, "In a large population of new Antidepressant users we found a significant association between degree of serotonin reuptake inhibition by Antidepressants and risk of hospital admission for abnormal bleeding as the primary diagnosis. An increased risk of abnormal bleeding was strongly associated with the degree of serotonin reuptake inhibition."

Source: Welmoed E. E. Meijer, PhD., et al., "Association of Risk of Abnormal Bleeding With Degree of Serotonin Reuptake Inhibition by Antidepressants," Archives of Internal Medicine, Vol. 164, November 22, 2004.

 

Drug Study, September 01, 2004

United States

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Adults (18 and over)

Side Effects: Aggression, Violence, Hostility, Mania, Psychosis,

Summary: A study in the journal Pediatrics revealed that 33% of the patients they studied that were exposed to Atomoxetine (Strattera) exhibited extreme irritability, aggression, mania or hypomania [mild-mania].

Source: Theodore A. Henderson, M.D., Ph.D. and Keith Hotman, M.D., "Aggression, Mania, and Hypomania Induction Associated with Atomoxetine," Pediatrics, Vol. 114, No. 3, September 2004.

 

Drug Study, August 20, 2004

United States

Drug Class: Antidepressant,

Generic Name: Sertraline, Citalopram, Venlafaxine, Bupropion, Paroxetine, Fluoxetine, Fluvoxamine, Nefazodone, Mirtazapine,

Brand Name: Zoloft, Celexa, Effexor, Wellbutrin, Zyban, Luvox, Serzone, Remeron,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: A Columbia University review of the pediatric clinical trials of Sertraline, Citalopram, Venlafaxine, Bupropion, Paroxetine, Fluoxetine, Fluvoxamine, Nefazodone and Mirtazapine found that young people who took them could experience suicidal thoughts or actions. Dr. Tarek Hammand of the FDA's Division of Neuropharmacological Drug Products performed an analysis based on the Columbia University review, and stated that his analysis also "...indicates a statistically significant association of suicidal events with Antidepressant drug treatment in short-term pediatric clinical trials for all indications."

Source: Office of Drug Safety, "Follow-up Consult of August 16, 2004 by Andrew Mosholder on Suicidality in pediatric clinical trials with paroxetine and other Antidepressant drugs...," August 16, 2004.

 

Drug Study, July 21, 2004

United States

Drug Class: Antidepressant,

Generic Name: Amitriptyline, Fluoxetine, Paroxetine,

Brand Name: Elavil, Endep, Vanatrip, Prozac, Paxil, Seroxat,

Age: Children (under 18), Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The Journal of the American Medical Association published a study that found there was a significantly higher risk of suicide and suicidal thoughts during the first 9 days of treatment with Antidepressants and that children who were first starting treatment were 4 times more likely to think about suicide, and 38 times more likely to commit suicide and that children as young as 5 had committed suicide while taking these drugs.

Source: Hershel Jick, MD, et al., "Antidepressants and the Risk of Suicidal Behaviors," Journal of the American Medical Association, Vol. 292, No. 3, July 21, 2004.

 

Drug Warning, June 03, 2004

Canada

Drug Class: Antidepressant,

Generic Name: Bupropion, Citalopram, Fluoxetine, Fluvoxamine, Mirtazapine, Paroxetine, Sertraline, Venlafaxine,

Brand Name: Wellbutrin, Zyban, Celexa, Prozac, Luvox, Remeron, Paxil, Seroxat, Zoloft, Effexor,

Age: Adults (18 and over), Children (under 18)

Side Effects: Abnormal Behavior, Emotional Changes, Self-Harm, Agitation, Irritability, Depression, Aggression, Violence, Hostility, Anxiety, Panic Attacks,

Summary: Health Canada issued an advisory to the public that stated that stronger warnings have been placed on Antidepressants. These warnings indicate that people taking these drugs at any age are at greater risk of behavioral or emotional changes including self-harm or harm to others. The advisory said, "A small number of patients taking drugs of this type may feel worse instead of better.... For example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts that could involve self-harm or harm to others." The drugs mentioned in this Advisory are Wellbutrin (bupropion), Zyban (bupropion), Celexa (citalopram), Prozac (fluoxetine), Luvox (fluvoxamine), Remeron (mirtazapine), Paxil (paroxetine), Zoloft (sertraline), Effexor (venlafaxine).

Source: Jirina Vlk, "Health Canada advises Canadians of stronger warnings for SSRIs and other newer anti-depressants," Health Canada, 2004-31, June 3, 2004.

 

Drug Warning, May 26, 2004

Canada

Drug Class: Antidepressant,

Generic Name: Sertraline,

Brand Name: Zoloft,

Age: Adults (18 and over)

Side Effects: Abnormal Behavior, Emotional Changes, Self-Harm,

Summary: Health Canada issued a safety alert to doctors on Zoloft saying it may be associated with behavioral and emotional changes including risk of self-harm.

Source: Bernard Prigent MD - Vice President & Medical Director Pfizer, "Health Canada Endorsed Important Safety Information on ZOLOFT (sertraline hydrochloride)," Health Canada, May 26, 2004.

 

Drug Warning, April 22, 2004

European Union

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide, Aggression, Violence, Hostility, Withdrawal Reactions,

Summary: The European Agency for the Evaluation of Medicinal Products issued a press release that reported that, according to clinical trials, Paroxetine-containing medicines could cause suicidal behavior and hostility in children. It recommended that Paroxetine not be used in children and recommended that young adults be observed carefully for signs and symptoms of suicidal behavior or hostility. Paroxetine was shown to have little effectiveness in children according to clinical trials. The committee also recommended strengthened warnings on the withdrawal symptoms of paroxetine, which are common.

Source: "European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products 20-22 April 2004" EMEA, The European Agency for the Evaluation of Medicinal Products, Press Release April 2004.

 

Drug Warning, March 22, 2004

United States

Drug Class: Antidepressant,

Generic Name: Mirtazapine, Fluoxetine, Sertraline, Paroxetine, Fluvoxamine, Citalopram, Escitalopram, Bupropion, Venlafaxine, Nefazodone,

Brand Name: Prozac, Paxil, Seroxat, Zoloft, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone, Remeron,

Age: Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide, Anxiety, Panic Attacks,

Summary: The FDA asked drug companies to add new warnings on 10 widely used Antidepressants. It said patients who used Prozac (fluoxetine), Zoloft (sertraline), Paxil (paroxetine), Luvox (fluvoxamine), Celexa (citalopram), Lexapro (escitalopram), Wellbutrin (bupropion), Effexor (venlafaxine), Serzone (nefazodone), and Remeron (mirtazapine) should be closely monitored for possible suicidal behavior and anxiety, especially when the patient first begins taking the drugs or changes doses.

Source: "Worsening Depression and Suicidality in Patients Being Treated with Antidepressant Medications," US Food and Drug Administration Public Health Advisory, March 22, 2004.

 

Drug Warning, March 22, 2004

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Sertraline, Paroxetine, Fluvoxamine, Citalopram, Escitalopram Oxalate, Bupropion, Venlafaxine, Mirtazapine, Nefazodone,

Brand Name: Prozac, Zoloft, Paxil, Seroxat, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone, Remeron,

Age: Adults (18 and over), Children (under 18)

Side Effects: Anxiety, Panic Attacks, Insomnia, Disturbed Sleep, Agitation, Irritability, Aggression, Violence, Hostility, Impulsivity, Akathisia, Mania, Psychosis,

Summary: The FDA issued a Public Health Advisory, stating: "Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia [severe restlessness], hypomania [abnormal excitement, mild mania] and mania [psychosis characterized by exalted feelings, delusions of grandeur and overproduction of ideas], have been reported in adult and pediatric patients being treated with Antidepressants."

Source: "WORSENING DEPRESSION AND SUICIDALITY IN PATIENTS BEING TREATED WITH Antidepressant MEDICATIONS," FDA Public Health Advisory, 22 Mar. 2004.

 

Drug Warning, February 03, 2004

Canada

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Paroxetine, Citalopram, Fluvoxamine, Mirtazapine, Sertraline, Venlafaxine,

Brand Name: Prozac, Paxil, Seroxat, Celexa, Luvox, Remeron, Zoloft, Effexor,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: Health Canada issued a warning to the public about Prozac, Paxil, Celexa, Luvox, Remeron, Zoloft and Effexor. The warning states that reports show an increased risk of suicide in children taking these drugs. Health Canada said its action was based on international studies that linked the use of these drugs to "suicide-related events," suicides and suicide attempts.

Source: "Health Canada advises Canadians under the age of 18 to consult physicians if they are being treated with newer anti-depressants", About Health Canada, February 2004.

 

Drug Warning, February 01, 2004

Australia

Drug Class: Antidepressant, Mood Stabilizer,

Generic Name: Lithium, Carbamazepine, Mirtazapine, Venlafaxine,

Brand Name: Eskalith, Eskalith CR, Lithobid, Carbatrol, Epitol, Equetro, Tegretol, Remeron, Effexor,

Age: Adults (18 and over)

Side Effects: Serotonin Syndrome,

Summary: The Australian Adverse Drug Reaction Bulletin issued a warning on certain drugs that could cause serotonin syndrome. These drugs are lithium; anticonvulsants such as carbamazepine; and newer and older Antidepressants such as mirtazapine, venlafaxine. Doctors need to be aware of these risks and fully inform patients of the risk and symptoms of the syndrome.

Source: "Serotonin Syndrome," Australian Adverse Drug Reactions, Vol. 23, No. 1, February 2004.

 

Drug Study, January 26, 2004

United States

Drug Class: Antidepressant,

Generic Name: Sertraline, Paroxetine, Fluoxetine, Citalopram, Bupropion, Venlafaxine,

Brand Name: Zoloft, Paxil, Seroxat, Prozac, Celexa, Wellbutrin, Effexor,

Age: Children (under 18), Adults (18 and over)

Side Effects: Suicide Risk, Suicide Attempts, Suicide, Aggression, Violence, Hostility,

Summary: Drug Safety Research issued a special report on newer Antidepressants that concluded, "The higher than expected numbers of suicidal and aggressive behaviors observed in some clinical trials of Antidepressants in children also can be seen in spontaneous adverse event data, and add substantial additional evidence to the case. The data show that suicidal/aggressive behaviors are reported in both adults and children, but more than twice as often in children. Finally, while two drugs now carry warnings about this risk, similar risks were reported for the four drugs without warnings."

Source: Thomas J. Moore, "Antidepressant Drugs and Suicidal/Aggressive Behaviors," Drug Safety Research - Special Report, Washington, D.C., January 26, 2004.

 

Drug Warning, December 10, 2003

United Kingdom

Drug Class: Antidepressant,

Generic Name:

Brand Name:

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The UK Medicines Control Agency issued new guidelines advising against prescribing newer Antidepressants, except Prozac, to anyone under 18 because of an increased risk of suicide.

Source: "British Warning on Antidepressant Use for Youth" New York Times October 11, 2003.

 

Drug Warning, November 10, 2003

Canada

Drug Class: Antidepressant,

Generic Name: Nefazodone,

Brand Name: Serzone,

Age: Adults (18 and over)

Side Effects: Liver Problems, Liver Failure, Liver Toxicity,

Summary: Health Canada announced it was overseeing the market withdrawal of the Antidepressant drug nefazodone (Serzone). Health Canada's safety evaluation of the drug found that nefazodone posed a risk of causing serious liver-related adverse effects. This risk posed a greater risk than other similar Antidepressants available in Canada.

Source: "Health Canada is overseeing the market withdrawal of the Antidepressant drug nefazodone," Health Canada, November 10, 2003.

 

Drug Warning, October 27, 2003

United States

Drug Class: Antidepressant,

Generic Name: Citalopram, Fluoxetine, Fluvoxamine, Mirtazapine, Nefazodone, Paroxetine, Sertraline, Venlafaxine,

Brand Name: Celexa, Prozac, Luvox, Remeron, Serzone, Paxil, Seroxat, Zoloft, Effexor,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The FDA released a "Health Advisory" where they announced that they had completed a preliminary review of reports of suicidality in pediatric patients for 8 Antidepressant drugs (both newer and older Antidepressants) and had determined that additional data and analysis and public discussion of available data were needed on the issue. The Health Advisory simply urged health care professionals to use the drugs with caution.

Source: Food and Drug Administration (FDA), "Reports of Suicidality in Pediatric Patients Being Treated with Antidepressant Medications for Major Depressive Disorder (MDD)" October 27, 2003.

 

Drug Warning, October 01, 2003

United Kingdom

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The Irish Medicines Board (IMB) announced that, based on the findings of recent Seroxat studies by GlaxoSmithKline, the drug was not effective in children and adolescents with "major depressive disorder" and showed an increased rate of self-harm and potentially suicidal behavior in this age group. The IMB considered that Seroxat should not be prescribed to people under 18.

Source: Irish Medicines Board, "SEROXAT (PAROXETINE) CONTRAINDICATED FOR CHILDREN" October 06, 2003.

 

Drug Warning, August 22, 2003

Canada

Drug Class: Antidepressant,

Generic Name: Venlafaxine,

Brand Name: Effexor,

Age: Children (under 18)

Side Effects: Aggression, Violence, Hostility, Suicide Risk, Suicide Attempts, Suicide,

Summary: Wyeth Pharmaceuticals, the makers of the Antidepressant Effexor, issued a warning to U.S. and Canadian doctors that use of this drug could cause hostility, suicidal ideation and self-harm in patients under the age of 18.

Source: Wyeth Pharmaceuticals, "Dear Health Care Professional..." Health Canada, Health Products and Food Branch, August 22, 2003.

 

Drug Warning, August 01, 2003

Australia

Drug Class: Antidepressant,

Generic Name: Paroxetine, Sertraline, Fluoxetine, Citalopram,

Brand Name: Paxil, Seroxat, Zoloft, Prozac, Celexa,

Age: Children (under 18), Adults (18 and over)

Side Effects: Withdrawal Reactions,

Summary: The Australian Therapeutic Goods Administration reported that the use of newer Antidepressants during or after pregnancy may result in adverse reactions to newborn babies, due to the withdrawal effect following intra-uterine exposure, or a toxic effect from ingestion of an Antidepressant in breast-milk. The withdrawal effects the baby experienced included agitation, jitteriness, poor feeding, sleepiness/lethargy, gastrointestinal symptoms and hypotania (deficient tone or tension).

Source: "Maternal SSRI Use and Neonatal Effects," The Australian Therapeutic Goods Administration, Adverse Drug Reactions Bulletin, Vol 22, No. August 4, 2003, p. 14.

 

Drug Study, July 15, 2003

Finland

Drug Class: Antidepressant,

Generic Name: Mirtazapine, Maprotiline, Mianserin, Nefazodone, Trazodone, Doxepin, Nortriptyline, Desipramine, Bupropion, Moclobemide, Venlafaxine, Dothiepin, Amitriptyline, Fluvoxamine, Imipramine, Citalopram, Fluoxetine, Sertraline, Clomipramine, Paroxetine,

Brand Name: Remeron, Ludiomil, Serzone, Desyrel, Oleptro, Adapin, Silenor, Sinequan, Aventyl, Pamelor, Wellbutrin, Zyban, Aurorix, Manerix, Effexor, Dothep, Elavil, Endep, Vanatrip, Luvox, Tofranil, Celexa, Prozac, Zoloft, Anafranil, Paxil, Seroxat, Norpramin, Pertofrane,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: A Finnish study published in The Archives of General Psychiatry found that infants whose mothers took newer Antidepressants during pregnancy could suffer neurological problems during their first week of life. The symptoms included tremors, restlessness and rigidity.

Source: "Newer Antidepressants Can Harm Newborns," Connecticut Post, July 15, 2003.

 

Drug Warning, July 01, 2003

Canada

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: Health Canada's Health Products and Food Branch warned health care professionals, "Until further information is available, Paxil should not be used in...pediatric patients...due to a possible increased risk of suicide-related adverse events in this patient population." Further, incidents of suicidal thoughts and self-harm were nearly twice as high on Paxil as on placebo (5.3% vs. 2.8%).

Source: Health Canada, "IMPORTANT DRUG SAFETY INFORMATION" Health Products and Food Branch, July 2003.

 

Drug Warning, June 19, 2003

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The U.S. FDA issued a statement that it was reviewing reports of increased risk of suicidal thinking and suicide attempts in children and adolescents using Paxil. The FDA noted that following the review of the same data, the UK department of health issued a press release saying that Paxil must not be used to treat depression in children and adolescents under the age of 18.

Source: "FDA Statement Regarding the Anti-Depressant Paxil for Pediatric Population," U.S. Food and Drug Administration, FDA Talk Paper, June 19, 2003.

 

Drug Warning, June 18, 2003

United Kingdom

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: GlaxoSmithKline issued a warning to British physicians against the use of Paxil in children, acknowledging failure of clinical trials to "demonstrate efficacy in major depressive disorders and doubling the rate of reported adverse events-including suicidal thoughts and suicide attempts-compared to placebo."

Source: Evelyn Pringle, "TeenScreen--Normal Kids Labeled Mentally Ill," OpEdNews, August 1, 2006.

 

Drug Warning, June 10, 2003

United Kingdom

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: UK's Medicines and Healthcare products Regulatory Agency (MHRA), warned that "Seroxat [Paxil] must not be used to treat depression in children and teenagers under the age of 18." The Department of Health stated, "It has become clear that the benefits of Seroxat in children, for the treatment of depressive illness, do not outweigh these risks." MHRA states that Seroxat is associated with an increased risk of self-harm and suicidal behavior and thoughts in people under the age of 18.

Source: Department of Health "SEROXAT MUST NOT BE USED FOR TREATMENT OF CHILDREN" Press Release R1191 - 12 Press Officer: Alison Langley, June 10, 2003.

 

Drug Study, May 01, 2003

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: GlaxoSmithKline submitted a report to the FDA which showed that children given Paxil (paroxetine) were more likely to become suicidal than those given placebos. It also showed that the drug did not improve their depression any better then placebo.

Source: Gardiner Harris, "Antidepressant Study Seen to Back Expert," The New York Times, August 20, 2004.

 

Drug Study, January 01, 2003

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Citalopram, Paroxetine, Sertraline, Fluvoxamine, Clomipramine, Imipramine, Lofepramine, Amitriptyline, Doxepin, Dothiepin, Desipramine, Trimipramine, Nortriptyline, Amoxapine, Maprotiline, Mianserin,

Brand Name: Prozac, Celexa, Paxil, Seroxat, Zoloft, Luvox, Anafranil, Tofranil, Gamanil, Tymelyt, Lomont, Elavil, Endep, Vanatrip, Adapin, Silenor, Sinequan, Prothiaden, Dothep, Thaden, Dopress, Surmontil, Aventyl, Pamelor, Asendin, Ludiomil, Norpramin, Pertofrane,

Age: Adults (18 and over)

Side Effects: Abnormal Bleeding,

Summary: The Archives of Internal Medicine published a study that examined the risk of upper gastrointestinal tract (GI) bleeding with use of Antidepressant medication. They concluded that there is an increased risk of upper GI bleeding when using any newer Antidepressants. Moreover, when aspirin was combined with newer Antidepressants, it increase the risk further.

Source: Susanne Oksbjerg Dalton, MD, et al.., "Use of Selective Serotonin Reuptake Inhibitors and Risk of Upper Gastrointestinal Tract Bleeding," Archives of Internal Medicine, Vol. 163, January 13, 2003.

 

Drug Study, January 01, 2001

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Bupropion, Nefazodone, Venlafaxine, Amitriptyline, Desipramine, Imipramine, Nortriptyline,

Brand Name: Prozac, Luvox, Paxil, Seroxat, Zoloft, Wellbutrin, Zyban, Serzone, Effexor, Elavil, Endep, Vanatrip, Tofranil, Aventyl, Pamelor, Norpramin, Pertofrane,

Age: Adults (18 and over)

Side Effects: Mania, Psychosis,

Summary: Journal of Clinical Psychiatry published a study that assessed the impact of behavior adverse reactions associated with the use of Antidepressants, such as psychosis and mania, leading to psychiatric hospital incarceration. The authors concluded that a significant proportion of psychiatric hospitalizations they reviewed, was due to Antidepressant associated psychotic or manic symptoms.

Source: Adrian Preda, MD., et al.., "Antidepressant-Associated Mania and Psychosis Resulting in Psychiatric Admissions," Journal of Clinical Psychiatry, Vol. 62, No. 1, January 2001.

 

Drug Study, October 01, 2000

United States

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Cancer, Tumors,

Summary: The American Journal of Epidemiology published two studies that demonstrated that Paxil presented a 720% increase in risk of breast cancer in females.

Source: M. Gotterchio et al.., "Antidepressant medication use on breast cancer," American Journal of Epidemiology, (Oct. 1, 2000), 152, 951-957.

 

Drug Warning, February 01, 2000

Australia

Drug Class: Antidepressant, Antianxiety,

Generic Name: Fluoxetine, Sertraline, Paroxetine, Citalopram, Temazepam, Diazepam, Oxazepam, Nitrazepam,

Brand Name: Prozac, Zoloft, Paxil, Seroxat, Celexa, Restoril, Valium, Serax, Mogadon,

Age: Adults (18 and over)

Side Effects: Nightmares,

Summary: The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin reporting that newer Antidepressants are commonly reported to cause nightmares and specifically mentioned Prozac, Zoloft, Paxil and Celexa.

Source: "Drug-induced nightmares," Australian Therapeutic Goods Administration, Adverse Drug Reactions Bulletin, Vol. 19, No. 1, February 2000.

 

Drug Warning, November 01, 1997

Australia

Drug Class: Antidepressant,

Generic Name: Fluoxetine, Fluvoxamine, Paroxetine, Sertraline,

Brand Name: Erocap, Lovan, Prozac, Zactin, Luvox, Aropax, Zoloft,

Age: Children (under 18)

Side Effects: Withdrawal Reactions,

Summary: The Australian Therapeutic Goods Administration (TGA) reported that there have been an increasing number of reports to the adverse drug reactions advisory committee on the effects of newer Antidepressants on newborns. Some of the reports described withdrawal reactions in newborns whose mothers had taken newer Antidepressants throughout their pregnancies; reports relate to probable breast milk transfer. Practitioners should consider this possibility when prescribing to depressed patients who are pregnant or breastfeeding.

Source: Therapeutic Goods Administration, "SSRIs and neonatal disorders..." Australian Adverse Drug Reactions Bulletin Volume 16, Number 4, November 1997.

 

Drug Study, July 01, 1997

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Adults (18 and over)

Side Effects: Aggression, Violence, Hostility, Suicide Risk, Suicide Attempts, Suicide,

Summary: In a Journal of Clinical Psychiatry study, Dr. John Zajecka reported that discontinuation [withdrawal] symptoms after treatment with Prozac can cause "aggressiveness and suicidal impulsivity."

Source: J. Zajecka, K. Tracy, and S. Mitchell, "Discontinuation Symptoms After Treatment with Selective Serotonin Reuptake Inhibitors: A Literature Review," Journal of Clinical Psychiatry, Vol. 58, July 1997.

 

Drug Study, December 01, 1995

United Kingdom

Drug Class: Antidepressant,

Generic Name: Paroxetine,

Brand Name: Paxil, Seroxat,

Age: Adults (18 and over)

Side Effects: Homicidal Ideation, Homicidal Actions, Suicide Risk, Suicide Attempts, Suicide, Withdrawal Reactions,

Summary: In the British journal Lancet, Dr. Miki Bloch of the National Institute of Mental Health and colleagues reported on patients who became suicidal and homicidal after stopping Paxil, including one man who was distraught over thoughts of harming "his own children."

Source: M. Bloch, S. V. Stager, A.R. Braun and D. R. Rainbow, "Severe Psychiatric Symptoms Associated with Paroxetine Withdrawal," Lancet, Vol. 346, December 1995.

 

Drug Study, January 28, 1995

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Adults (18 and over)

Side Effects: Suicide Risk , Suicide Attempts, Suicide,

Summary: In a study in British Medical Journal entitled "Antidepressants and Suicide" one of the authors stated, "The results indicate that only fluoxetine [Prozac] has a rate [of suicide] that seems to be substantially higher than that of other Antidepressants."

Source: Susan S. Jick, Alan D. Dean and Hershel Jick, "Antidepressants and Suicide," British Medical Journal, Vol. 310, Jan. 28, 1995.

 

Drug Study, April 01, 1994

United Kingdom

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Adults (18 and over)

Side Effects: Suicide Risk , Suicide Attempts, Suicide,

Summary: In a study published in CNS Drugs, the director of Cardiff's University's North Wales department of psychological medicine, confirmed, "Some of the case reports regarding fluoxetine-induced suicidal ideation do appear sufficiently well documented and detailed to sustain an argument that fluoxetine may lead to the emergence of suicidal ideation."

Source: David Healy, M.D. "The Fluoxetine and Suicide Controversy: A Review of the Evidence," CNS Drugs, Vol. 1, No. 3, 1994.

 

Drug Study, May 01, 1993

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Children (under 18), Adults (18 and over)

Side Effects: Birth Defects,

Summary: A study published in the Journal of The American Medical Association found that out of 117 mother who took Prozac during the first trimester had a 14.8% risk of miscarriage compared to 7.8% in mothers not exposed to fluoxetine or tricyclic Antidepressants. There were 19 spontaneous abortions and 13 abnormalities, including heart and small intestine defects in the Prozac group. One baby was born with clubfeet, and a second with a congenital dislocation of the hip. In comparison, there were 10 spontaneous abortions and 4 anomalies in the non-drug group.

Source: Anne Pastuszak, BSc, et al., "Pregnancy Outcome Following First-Trimester Exposure to Fluoxetine (Prozac)," Journal of The American Medical Association, Vol. 269, No. 17, May 5, 1993.

 

Drug Study, December 01, 1991

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Adults (18 and over)

Side Effects: Akathisia, Suicide Risk , Suicide Attempts, Suicide,

Summary: The Journal of Clinical Psychiatry published a study which stated, "Three depressed inpatients, 25-47 years of age, were re-exposed to fluoxetine after having previously made a serious suicide attempt while taking the drug. This is the first report, to our knowledge, of patients restarted on fluoxetine after a previous suicide attempt during fluoxetine treatment.... We observed that all three patients developed severe akathisia [severe restlessness] while taking fluoxetine, and they stated that the development of this syndrome, in the context of their depressive episode, is what precipitated their prior suicide attempts. When re-exposed to fluoxetine, the patients again developed akathisia and suicidal ideation. The suicidal feelings abated when the akathisia was treated by the discontinuation of the fluoxetine...."

Source: Anthony J. Rothschild, M.D., and Carol A. Locke, M.D., "Reexposure to Fluoxetine After Serious Suicide Attempts by Three Patients: The Role of Akathisia," Journal of Clinical Psychiatry, December 1991.

 

Drug Study, March 01, 1991

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Children (under 18)

Side Effects: Suicide Risk, Suicide Attempts, Suicide,

Summary: The Journal of the American Academy of Child and Adolescent Psychiatry published a study on three boys and three girls, age 10 to 17 years old, who "developed intense self-injurious ideation or behavior while receiving fluoxetine for treatment of obsessive-compulsive disorder.... Three patients made suicide gestures or attempts, one of which involved a massive overdose of fluoxetine. Three patients manifested persistent, driven self-injurious behavior and/or ideation that required restraints, seclusion, or one-on-one nursing care. Suicidal ideation or self-injurious behavior persisted up to one month after the fluoxetine was discontinued."

Source: Robert King, M.D., et al., "Emergency of Self-Destructive Phenomena in Children and Adolescents during Fluoxetine Treatment," Journal of the American Academy of Child and Adolescent Psychiatry, March 1991.

 

Drug Study, February 07, 1991

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Adults (18 and over)

Side Effects: Suicide Risk , Suicide Attempts, Suicide,

Summary: It was reported in The New England Journal of Medicine that there is a strong association in patients whom have suicidal ideation and are on fluoxetine treatment. They reported on a 58-year-old man who "was started on fluoxetine (20 mg/day). Three days later he had violent suicidal thoughts and tried to hang himself with a rope. The fluoxetine was discontinued, with a complete disappearance of suicidal ideation four days later."

Source: Prakash Marsand, M.D., et al., "Suicidal Ideation Related to Fluoxetine Treatment," The New England Journal of Medicine, February 7, 1991.

 

Drug Study, August 01, 1990

United States

Drug Class: Antidepressant, Mood Stabilizer,

Generic Name: Lithium,

Brand Name: Eskalith, Eskalith CR, Lithobid,

Age: Adults (18 and over)

Side Effects: Toxicity,

Summary: A Journal of Clinical Psychiatry study describe two cases of elderly patients that developed significant nerve tissue damage (neurotoxicity) with treatment of normal doses of an Antidepressant and lithium.

Source: "Toxicity resulting from lithium augmentation of Antidepressant treatment in elderly patients," Journal of Clinical Psychiatry, Vol. 51, No. 8, pp 344-5, August 1990.

 

Drug Study, February 01, 1990

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Adults (18 and over), Children (under 18)

Side Effects: Suicide Risk , Suicide Attempts, Suicide,

Summary: Harvard doctors Martin Teicher and Jonathan Cole reported in the American Journal of Psychiatry that six of their patients had developed "intense, violent suicidal" thoughts soon after starting Prozac. One patient reported feeling like "jumping out of her skin." So great was her "anxiety, fear, and turbulence that she felt 'death would be a welcome result." Another patient "became violent, banging her head and mutilating herself...."

Source: Martin Teicher, M.D. and Jonathan Cole, M.D., "Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment" American Journal of Psychiatry, Vol. 147, Is. 2, February 1990.

 

Drug Warning, May 01, 1989

United Kingdom

Drug Class: Antidepressant, Mood Stabilizer,

Generic Name: Lithium, Fluoxetine, Fluvoxamine,

Brand Name: Prozac, Luvox, Eskalith, Eskalith CR, Lithobid,

Age: Adults (18 and over)

Side Effects: Serotonin Syndrome, Convulsions, Involuntary Movements, Muscle Spasms,

Summary: The Medicines and Healthcare products Regulatory Agency published warnings in their Current Problems bulletin, about fluvoxamine and fluoxetine interactions with older Antidepressants, lithium, and tryptophan. The combinations can increase the risk of severe side effects such as serotonin syndrome, tremor and convulsions.

Source: "Serious interaction between tamoxifen and warfarin," Current Problems, MHRA, No. 26, May 1989.

 

Drug Study, March 01, 1986

United States

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Adults (18 and over)

Side Effects: Depression,

Summary: An FDA safety reviewer of Prozac determined it "may exacerbate [worsen] certain depressive symptoms and signs." Further, "Certain clinical risks of mild to moderate severity did appear to be associated with the use of [Prozac]...These potential risks include intensification of the vegetative [functioning involuntarily or unconsciously] signs and symptoms of depression."

Source: Richard Kapit, M .D., Safety Review of NDA 18-936 (Fluoxetine) of 23 Mar. 1986.

 

Drug Study, May 01, 1984

Germany

Drug Class: Antidepressant,

Generic Name: Fluoxetine,

Brand Name: Prozac,

Age: Adults (18 and over)

Side Effects: Suicide Risk , Suicide Attempts, Suicide,

Summary: The German Drug Regulatory Authority, BfArM, reported that during a study of Prozac (fluoxetine) there were 16 attempted suicides, of which two were successful. As patients with a suicide risk were excluded from the studies, "it is probable that this high proportion can be attributed to an action of the preparation [Prozac]...."

Source: Kelly O'Meara, Psyched Out, How Psychiatry Sells Mental Illness and Pushes Pills that Kill, AuthorHouse, 2006, p. 115.

 

Drug Warning, 2000

Australia

Drug Class: Antidepressant,

Generic Name: Mirtazapine,

Brand Name: Remeron, Avanza, Mirtazon,

Age: Adults (18 and over)

Side Effects: Convulsions, Seizures, Muscle Spasms, Blood Disorders, Agitation, Irritability, Nightmares, Hallucinations, Delusional Thinking, Sensory Disturbances,

Summary: The Australian Therapeutic Goods Administration reported that older Antidepressants Remeron, Avanza and Mirtazon could cause potential serious reactions such as convulsions, blood clots, anxiety, agitation, blood disorders, nightmares, and hallucinations.

Source: "Convulsions and Blood Dyscrasias with Mirtazapine," The Australian Therapeutic Goods Administration (TGA), Adverse Drug Reactions Bulletin, Vol. 22, No. 5, October 2003, p. 18.

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