Your filter specification- Drug Class~~Name- Mood Stabilizer
40 Entries Found
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, July 08, 2011
Canada
Drug Class: Mood Stabilizer,
Generic Name: Valproic Acid,
Brand Name: Depakote, Depakene, Depacon, Epilim,
Age: Adults (18 and over), Children (under 18)
Side Effects: Birth Defects, Cognitive Impairment,
Summary: Health Canada issued a public warning about the risks of using the anti-epileptic valproate (valproic acid, divalproex sodium) while pregnant (note: Valporate is FDA approved to treat bipolar). They reiterated the risks of birth defects caused in children whose mothers took valproate while pregnant. But more recently, studies have found that these children also had lower cognitive abilities.
Source: "Valproate anti-epileptic drugs may pose risks to children when taken by mothers during pregnancy," Health Canada, 8 July 2011, http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_90-eng.php.
Drug Warning, June 30, 2011
United States
Drug Class: Mood Stabilizer,
Generic Name: Valproic Acid,
Brand Name: Depakote, Depakene, Depacon, Epilim,
Age: Adults (18 and over), Children (under 18)
Side Effects: Birth Defects, Cognitive Impairment,
Summary: The FDA notified healthcare professionals that children born to mothers who take the anti-seizure medication valproate sodium (also approved to treat bipolar) or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.
Source: "Valproate Products: Drug Safety Communication - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)," Food and Drug Administration, 30 June 2011.
Drug Study, April 01, 2011
United States
Drug Class: Antipsychotic, Mood Stabilizer,
Generic Name: Haloperidol, Risperidone, Olanzapine, Quetiapine, Valproate,
Brand Name: Haldol, Risperdal, Zyprexa, Seroquel, Depakene, Depakote,
Age: Adults (18 and over)
Side Effects: Death,
Summary: A study reported at the annual meeting of the American Association for Geriatric Psychiatry found that Veterans Affairs data on 4,854 patients aged 65 and older with bipolar disorder showed that the risk of death within 180 days of receiving an antipsychotic prescription was highest for haloperidol, followed by risperidone, olanzapine, and quetiapine; valproate was associated with the lowest excess risk.
Source: Neil Osterweil, "Antipsychotics Increase Mortality Risk in Older Adults With Bipolar Disorder," International Medicine News, 4 Apr 2011.
Drug Study, January 01, 2011
United States
Drug Class: Antipsychotic, Mood Stabilizer, Antianxiety,
Generic Name:
Brand Name:
Age: Adults (18 and over)
Side Effects: Falls,
Summary: The Journal of the American Geriatrics Society published a summary on the updated American Geriatrics Society/British Geriatrics Society Clinical Practice Guideline for Prevention of Falls in Older Persons. The guidelines stated to reduce the risk of falls, medication reduction or withdrawal is stressed for all older people, particularly psychoactive drugs.
Source: Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics Society (2011), Summary of the Updated American Geriatrics Society/British Geriatrics Society Clinical Practice Guideline for Prevention of Falls in Older Per
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: Mood Stabilizer,
Generic Name: Lamotrigine,
Brand Name: Lamictal,
Age: Adults (18 and over)
Side Effects: Skin Problems, Skin Reactions,
Summary: The Australian Therapeutic Goods Administration issued a warning in their Medicines Safety Update Bulletin about Lamotrigine (Mood Stabilizer used for bipolar) causing serious skin reactions, which can potentially be fatal. Stevens-Johnson syndrome (a type of life-threatening severe rash) and toxic epidermal necrolysis (where the outer layers of the skin die) can develop following the administration of Lamotrigine. The warning advises that Lamotrigine is discontinued at first sign of rash (unless obviously not caused by the drug).
Source: "Lamotrigine and serious skin reactions," Medicines Safety Update, No. 6, December 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 Warning, December 01, 2010
New Zealand
Drug Class: Mood Stabilizer, Antianxiety,
Generic Name:
Brand Name:
Age: Adults (18 and over)
Side Effects: Sleepwalking, Withdrawal Reactions, Agitation, Insomnia,
Summary: MedSafe in New Zealand issued an update to prescribers, discouraging them from using hypnotics and benzodiazepines for treatment of insomnia, and that patients need to be informed about the side effects of the drugs such as sleepwalking, sleep eating, etc. In addition, those who have been on long-term treatment with benzodiazepines and sedatives for insomnia should be encouraged to gradually withdraw from treatment. They need to slowly taper off of their dose over a number of months to help reduce the withdrawal effects such as agitation, anxiety and insomnia.
Source: "Hypnotics and anxiolytics - a wake-up call," MedSafe, Dec. 2010, http://www.medsafe.govt.nz/profs/PUArticles/HypnoticsAndAnxiolytics.htm.
Drug Warning, July 01, 2010
Canada
Drug Class: Mood Stabilizer,
Generic Name: Pregabalin,
Brand Name: Lyrica,
Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: Health Canada issued an alert about the mood-stabilizing drug pregabalin (Lyrica - used for bipolar, mania and manic depression) and reports of suicidal ideation and attempts they have received related to this drug. They warned that health care professionals need to be aware of and monitor for these adverse reactions suspected to be associated with this drug.
Source: "Pregabalin (Lyrica): suicidal ideation and attempt," Canadian Adverse Reaction Newsletter, Volume 20, Issue 3, July 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
United States
Drug Class: Mood Stabilizer,
Generic Name:
Brand Name:
Age: Adults (18 and over)
Side Effects: Drug Toxicity,
Summary: American Journal of Preventive Medicine published a study that found hospitalizations due to poisonings from prescription sedatives and tranquilizers increased 65% between 1999 and 2006.
Source: Jeffrey H. Coben, MD, et al., "Hospitalizations for Poisoning by Prescription Opioids, Sedatives, and Tranquilizers," American Journal of Preventive Medicine, Vol. 38, Iss. 5, May 2010.
Drug Study, April 14, 2010
United States
Drug Class: Mood Stabilizer,
Generic Name: Topiramate, Carbamazepine,
Brand Name: Topamax, Topiragen, Carbatrol, Epitol, Equetro, Tegretol,
Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: A study published in the Journal of the American Medical Association evaluated the risk of suicidal acts and combined suicidal acts or violent death associated with individual anticonvulsants (used to treat bipolar disorder and mania). The author's conclusion was essentially that some anticonvulsants have a higher risk of suicidal acts/violent deaths then others. However, they also acknowledge that anticonvulsant medications in general can have psychotropic effects, including mood and behavior changes. Additionally, that their findings are compatible with the FDA analysis that warranted labeling on all anticonvulsant medications warning of the an increased risk of suicidal thoughts and behaviors.
Source: Elisabetta Patorno, et al., "Anticonvulsant Medications and the Risk of Suicide, Attempted Suicide, or Violent Death," Journal of the American Medical Association, vol. 303, no. 14, April 14, 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 Warning, December 03, 2009
United States
Drug Class: Mood Stabilizer,
Generic Name: Valproic Acid,
Brand Name: Depakote, Depakene, Depacon, Epilim,
Age: Children (under 18), Adults (18 and over)
Side Effects: Birth Defects,
Summary: The FDA notified health care professionals and patients about the increased risk of a birth defect that creates an opening anywhere in the baby's spinal column, as well as other major birth defects, such as skull defects and heart malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy.
Source: "Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects," FDA.gov, Dec 3, 2009, URL http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm
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, May 19, 2009
Switzerland
Drug Class: Mood Stabilizer,
Generic Name: Lithium,
Brand Name: Eskalith, Eskalith CR, Lithobid,
Age: Adults (18 and over)
Side Effects: Altered Thyroid Function, Kidney Problems, Gastrointestinal Symptoms, Diarrhea, Seizures, Motor Impairment, Muscle Spasms, Urinary Problems, Weight Gain , Swelling, Water Retention, Skin Problems, Skin Reactions,
Summary: The journal CNS Drugs published a study where authors reviewed safety data on lithium that was available to date. They found typical complaints of patients on long-term lithium were: Gastrointestinal pain or discomfort, diarrhea, tremor, urination problems, weight gain, abnormal water retention, and skin redness/irritation. Kidney problems and changed thyroid functions were also fairly common.
Source: "Lithium: Updated Human Knowledge Using an Evidence-Based Approach: Part III: Clinical Safety," CNS Drugs, Vol. 23, No. 5, May 19, 2009.
Drug Warning, May 05, 2009
United States
Drug Class: Mood Stabilizer,
Generic Name: Carbamazepine,
Brand Name: Carbatrol, Epitol, Equetro, Tegretol,
Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA released a notification to healthcare professionals and patients of the approved label change for antiepileptic drugs used to treat psychiatric disorders, and other conditions. The update on the drug's label now includes the increased risk of suicidal thoughts or behavior, which was generally consistent among the drugs.
Source: "2008 Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics)," FDA MedWatch, May 5, 2009.
Drug Warning, April 01, 2009
Australia
Drug Class: Mood Stabilizer,
Generic Name: Valproic Acid,
Brand Name: Depakote, Depakene, Depacon, Epilim,
Age: Children (under 18), Adults (18 and over)
Side Effects: Birth Defects,
Summary: The Australian Adverse Drug Reaction Bulletin, Vol. 28, No. 2, published a report called "Serious reaction reminders...sodium valproate and fetal malformations." The bulletin goes over some of the serious risks of sodium valproate (approved to treat mania). Specifically, that it is well known to cause fetal malformations and is classified as a Pregnancy Category D drug (drugs that have caused, are suspected to have caused or may be expected to cause an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects).
Source: "Serious reaction reminders...sodium valproate and fetal malformations," The Australian Adverse Drug Reaction Bulletin, Vol. 28, No. 2, April 2009.
Drug Warning, April 01, 2009
United Kingdom
Drug Class: Mood Stabilizer,
Generic Name: Carbamazepine, Phenobarbital,
Brand Name: Carbatrol, Epitol, Equetro, Tegretol, Solfoton,
Age: Adults (18 and over)
Side Effects: Weak or Fragile Bones, Lowered Bone Mineral Density, Lowered Bone Mass,
Summary: The UK's Medicines and Healthcare products Regulatory Agency published in their Drug Safety Update report entitled, "Antiepileptics: adverse effects on bone," that available data suggest that long-term use of [specific antiepileptics] is associated with decreased bone mineral density that may lead to osteopenia [bone mineral density being lower than normal], osteoporosis [bone disease in which bones become porous and break easy and heal slow], and increased fractures in at-risk patients. Vitamin D supplementation should be considered for at-risk patients who are taking these medicines long term. These drugs are used as Mood Stabilizers for mania, Bipolar and manic depression.
Source: "Antiepileptics: Adverse effects on bone," Drug Safety Advice, MHRA, Vol. 2, Iss. 9, April 2009.
Drug Warning, February 01, 2009
Ireland
Drug Class: Mood Stabilizer,
Generic Name: Carbamazepine, Valproic Acid, Gabapentin, Lamotrigine, Oxcarbazepine, Pregabalin, Topiramate,
Brand Name: Carbatrol, Equetro, Tegretol, Depakote, Depakene, Depacon, Epilim, Neurontin, Lamictal, Trileptal, Lyrica, Topamax,
Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: Irish Medicines Board's Drug Safety Newsletter published new information about antiepileptic drugs, used for mania, bipolar, and manic-depressive disorder. They say that antiepileptic drugs may be associated with a small risk of suicidal thoughts and behavior. Further, that drug package information must include this new risk in their writings.
Source: Antiepileptic Medicines: Risk of suicidal thoughts and behavior," Drug Safety Newsletter, IMD, Iss. 29, February 2009.
Drug Warning, December 16, 2008
United States
Drug Class: Mood Stabilizer,
Generic Name: Carbamazepine, Valproic Acid,
Brand Name: Carbatrol, Equetro, Tegretol, Depakote, Depakene, Depacon, Epilim,
Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA completed an analysis of reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, the FDA now requires that all manufacturers of antiepileptic drugs include a warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.
Source: "2008 Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics)," MedWatch, December 16, 2008.
Drug Study, May 01, 2008
Israel
Drug Class: Antipsychotic, Mood Stabilizer,
Generic Name: Lithium, Quetiapine,
Brand Name: Seroquel, Eskalith, Eskalith CR, Lithobid,
Age: Adults (18 and over)
Side Effects: Toxicity, Delusional Thinking, Psychosis,
Summary: The Journal of Clinical Neuropharmacology published a study titled, "Delirium Associated With Lithium-Quetiapine Combination." The study found that that lithium-induced neurotoxicity should be suspected in any patient receiving lithium in combination with neuroleptics or any other clinical variable. In such cases, regardless of lithium serum levels, the clinician should consider immediate discontinuation of the medication. They reported on a specific case of a patient who was treated with lithium-quetiapine and had experienced psychiatric symptoms such as delirium, which cleared up when lithium was stopped.
Source: "Delirium Associated With Lithium-Quetiapine Combination" Clinical Neuropharmacology, Vol. 31, Iss. 3, pp 176-179, May/June 2008.
Drug Warning, March 17, 2008
Canada
Drug Class: Mood Stabilizer,
Generic Name: Carbamazepine,
Brand Name: Tegretol,
Age: Adults (18 and over)
Side Effects: Skin Problems, Skin Reactions,
Summary: Health Canada sent out a letter to health care professionals on the subject of "New Safety Information for the anti-epileptic drug Tegretol." Tegretol is an anti-epileptic drug that is also used to treat mania, Bipolar Disorder, Manic-Depression, and Attention Deficit Disorder with Hyperactivity. Health Canada warned that serious and sometimes fatal dermatological reactions, including Toxic Epidermal Necrolysis (life-threatening skin disorder, characterized by blistering and peeling of the top layer of skin) and Stevens-Johnson Syndrome (severe inflammation of the skin), have been reported with Tegretol.
Source: "Health Canada Endorsed Important Safety Information on TEGRETOL (carbamazepine)," Health Canada, March 17, 2008.
Drug Warning, March 01, 2008
United States
Drug Class: Mood Stabilizer,
Generic Name: Valproic Acid,
Brand Name: Depakote, Depakene, Depacon, Epilim,
Age: Adults (18 and over)
Side Effects: Hypothermia, Suicide Risk, Suicide, Altered Thyroid Function,
Summary: FDA's MedWatch added a warning to Depakote (anticonvulsant) prescribed often to counter psych drug reactions and prevent seizures caused by them. Depakote is also FDA approved to treat Mania. The packaging must now warn that Hypothermia (dropped body core temperature) has reported in association with Depakote use; Suicidal ideation may manifest; and reports of altered thyroid function tests associated with valproate.
Source: "Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - March 2008," FDA MedWatch, March 2008.
Drug Warning, February 01, 2008
New Zealand
Drug Class: Mood Stabilizer,
Generic Name: Carbamazepine, Valproic Acid, Gabapentin, Lamotrigine, Oxcarbazepine, Pregabalin, Topiramate,
Brand Name: Carbatrol, Equetro, Tegretol, Depakote, Depakene, Depacon, Epilim, Neurontin, Lamictal, Trileptal, Lyrica, Topamax,
Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: MedSafe in New Zealand sent out a letter to doctors and pharmacies about the risk of suicidal thoughts and behavior with antiepileptic (mood-stabilizing) drugs.
Source: "Anti-epileptics - Monitor patients for increased risk of suicidality," Medsafe, Alerts/Letters, February 1, 2008.
Drug Warning, January 31, 2008
United States
Drug Class: Mood Stabilizer,
Generic Name: Carbamazepine, Valproic Acid, Gabapentin, Lamotrigine, Oxcarbazepine, Pregabalin, Topiramate,
Brand Name: Carbatrol, Equetro, Tegretol, Depakote, Depakene, Depacon, Epilim, Neurontin, Lamictal, Trileptal, Lyrica, Topamax,
Age: Adults (18 and over)
Side Effects: Suicide Risk, Suicide Attempts, Suicide,
Summary: The FDA put out a warning to healthcare professionals about the risk of suicidal thoughts and behavior with antiepileptic drugs, used for mood-stabilizing purposes. The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the drug and continued through 24 weeks.
Source: "Suicidality and Antiepileptic Drugs," FDA Alert, January 31, 2008.
Drug Warning, December 12, 2007
United States
Drug Class: Mood Stabilizer,
Generic Name: Carbamazepine,
Brand Name: Carbatrol, Equetro, Tegretol,
Age: Adults (18 and over)
Side Effects: Skin Problems, Skin Reactions,
Summary: The FDA issued, "Information for Healthcare Professionals Carbamazepine (Carbatrol, Equetro, Tegretol, and generics)." Carbamazepine is a mood-stabilizing drug that the FDA approved for treatment of mania/bipolar disorder, among other things. The FDA sent out an alert that a dangerous or even fatal skin reactions that can be caused by carbamazepine, are significantly more common in patients with a particular genetic trait almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians.
Source: "Information for Healthcare Professionals Carbamazepine (Carbatrol, Equetro, Tegretol, and generics)," FDA MedWatch, December 12, 2007.
Drug Study, May 01, 2006
United Kingdom
Drug Class: Mood Stabilizer,
Generic Name: Lithium,
Brand Name: Eskalith, Eskalith CR, Lithobid,
Age: Adults (18 and over)
Side Effects: Altered Thyroid Function, Weight Gain, Kidney Problems,
Summary: The Journal of Psychopharmacology published a study on key adverse events from Lithium which affect the body. This included thyroid changes, weight gain, and kidney problems. They stress that clinicians prescribing lithium need to be aware of these adverse events.
Source: "Lithium: a review of its metabolic adverse effects." Journal of Psychopharmacology, Vol. 20, No. 3, pp. 347-55, May 2006.
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 Warning, July 01, 2000
United States
Drug Class: Mood Stabilizer,
Generic Name: Valproic Acid,
Brand Name: Depakote, Depakene, Depacon, Epilim,
Age: Adults (18 and over)
Side Effects: Inflammation of the Pancreas,
Summary: Abbott Laboratories sent out a "Dear Healthcare Professional" letter to prescribers about an update to the warnings section in the valproate family of mood-stabilizing drugs (such as Depakote and Depakene). The drug will now carry a warning about the development of potentially fatal cases of pancreatitis. Valproate has been increasingly prescribed as a Mood Stabilizer in both schizophrenia and bipolar disorder.
Source: Dear Healthcare Professional," Abbott Laboratories, July 2000.
Drug Study, April 01, 1999
United States
Drug Class: Mood Stabilizer,
Generic Name: Lithium,
Brand Name: Eskalith, Eskalith CR, Lithobid,
Age: Adults (18 and over)
Side Effects: Altered Thyroid Function,
Summary: The Journal of Clinical Psychiatry published a study that evaluated lithium's affect on the thyroid. They found that lithium interfered with thyroid function and increased the incidence of low thyroid production.
Source: "Lithium-induced subclinical hypothyroidism: review of the literature and guidelines for treatment." Journal of Clinical Psychiatry, Vol. 60, No. 4, pp 249-55, April 1999.
Drug Study, August 01, 1997
Slovenia
Drug Class: Mood Stabilizer,
Generic Name: Lithium,
Brand Name: Eskalith, Eskalith CR, Lithobid,
Age: Adults (18 and over)
Side Effects: Toxicity,
Summary: The journal of Clinical Neuropharmacology published an overview report that showed significant nerve tissue damage (neurotoxicity) caused by lithium.
Source: "Irreversible lithium neurotoxicity: an overview," Clinical Neuropharmacology, Vol. 20, No. 4, pp 283-99, August 1997.
Drug Study, July 01, 1995
United States
Drug Class: Mood Stabilizer,
Generic Name: Lithium,
Brand Name: Eskalith, Eskalith CR, Lithobid,
Age: Adults (18 and over)
Side Effects: Seizures, Motor Impairment, Muscle Spasms,
Summary: The Journal of Clinical Psychiatry published a study that looked at the rate of tremor side effects from lithium use. The authors found that because of the frequency of tremors, patients should be tested for lithium tremor on a regular basis.
Source: "Lithium tremor," Journal of Clinical Psychiatry, Vol. 56, No. 7, pp 283-7, July 1995.
Drug Study, July 01, 1993
Australia
Drug Class: Mood Stabilizer,
Generic Name: Lithium,
Brand Name: Eskalith, Eskalith CR, Lithobid,
Age: Adults (18 and over)
Side Effects: Toxicity,
Summary: The journal Kidney International Supplement, published a study that described how patients who have urination problems are at an increased risk of acute lithium toxicity because of the excessive loss of kidney fluids.
Source: "Lithium nephrotoxicity," Kidney International Supplement, Vol. 22, pp S93-8, July 1993.
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, June 01, 1990
United States
Drug Class: Mood Stabilizer,
Generic Name: Lithium,
Brand Name: Eskalith, Eskalith CR, Lithobid,
Age: Adults (18 and over)
Side Effects: Cranial Pressure,
Summary: The Journal of Clinical Psychiatry published a study that reported on two patients being treated with lithium and suffered from increased cranial pressure (pressure within their brain, but with an absence of a tumor). The authors cautioned that patients on lithium need to be carefully monitor to avoid such side effects.
Source: "Pseudotumor cerebri associated with lithium therapy in two patients," Journal of Clinical Psychiatry, Vol. 51, No. 6, pp 251-3, June 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, June 21, 1905
United States
Drug Class: Mood Stabilizer, Antipsychotic,
Generic Name: Valproic Acid, Lithium,
Brand Name: Depakote, Depakene, Depacon, Epilim, Eskalith, Eskalith CR, Lithobid,
Age: Adults (18 and over)
Side Effects: Weight Gain,
Summary: The Journal of Clinical Psychiatry published a study that reiterated the weight gain complication association found with Lithium, Valproic Acid and antipsychotic drugs. And for many, weight gain is so problematic, they discontinue treatment. Patients who continue drug treatment are at risk for significant weight gain, which may be difficult to loose, even after the drug is stopped.
Source: "Weight gain associated with use of psychotropic medications," Journal of Clinical Psychiatry, Vol. 60, Suppl. 21, pp 16-9, 1999.