Fwd: FDA Drug Warning: Anti-Seizure/ Mood Stabilizers Increase Risk of Suicide Attempts

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIUnderscoring the fact that certain prescription drugs can and do precipitatesuicide, FDA acknowledges that four of the patients who were randomized toreceive one of the antiepileptic drugs committed suicide, whereas none ofthe patients in the placebo group did.Perhaps one of the last actions taken by the FDA is to require warningsabout increased risks of suicide attempts ("suicidality") for a very largeclass of drugs originally approved for the treatment of epilepsy but whoseprofits come from their mostly off-label use for pain or psychiatricconditions (in which case they're called, Mood Stabilizers). [see listbelow]The FDA convened an advisory committee hearing after the agency's review of199 clinical trials of 11 anti-epileptic drugs showed that patientsprescribed these drugs doubled their risk of engaging in suicidal behavioror thoughts (0.43 percent) compared to patients receiving a placebo (0.24percent). This difference translates into one in 500 patients taking ananti-seizure (mood stabilizer) drug is at risk of making a suicideattempt--regardless of the condition for which the drug was prescribed.However, FDA only issued a half hearted warning--no Black Box Warning ofsuicidality as required on the labels of the SSRI antidepressants.  This isstrange inasmuch as anti-seizure drugs are prescribed mostly with otherpsychotropic drugs--such as SSRIs and antipsychotics--and these drugs ALSOincrease the risk of suicide!One would think that a cumulative increased risk of such a seriousdrug-induced effect would warrant bolder warnings rather than a muted one. We also suggest that psychiatrists who claim that the suicide rate amongAmerican youth has increased in recent years--a matter of dispute--shouldcheck the drug cocktails that children and adolescents are being prescribed,mostly by child psychiatrists.Contact: Vera Hassner Sharavveracare212-595-8974~~~~~~~~~~~~~~~~~~~FOR IMMEDIATE RELEASEDec. 16, 2008 Media Inquiries:Sandy Walsh, 301-796-4669Consumer Inquiries: 888-INFO-FDAFDA Requires Warnings about Risk of Suicidal Thoughts and Behavior forAntiepileptic MedicationsThe U.S. Food and Drug Administration today announced it will require themanufacturers of antiepileptic drugs to add to these products' prescribinginformation, or labeling, a warning that their use increases risk ofsuicidal thoughts and behaviors (suicidality). The action includes allantiepileptic drugs including those used to treat psychiatric disorders,migraine headaches and other conditions, as well as epilepsy.The FDA is also requiring the manufacturers to submit for each of theseproducts a Risk Evaluation and Mitigation Strategy, including a MedicationGuide for patients. Medication Guides are manufacturer-developed handoutsthat are given to patients, their families and caregivers when a medicine isdispensed. The guides will contain FDA-approved information about the risksof suicidal thoughts and behaviors associated with the class ofantiepileptic medications."Patients being treated with antiepileptic drugs for any indication shouldbe monitored for the emergence or worsening of depression, suicidal thoughtsor behavior, or any unusual changes in mood or behavior," said Russell Katz,M.D., director of the Division of Neurology Products in the FDA's Center forDrug Evaluation and Research. " Patients who are currently taking anantiepileptic medicine should not make any treatment changes without talkingto their health care professional."The FDA today also disseminated information to the public about the risksassociated with antiepileptic medications by issuing a public healthadvisory and an information alert to health care professionals. Health careprofessionals should notify patients, their families, and caregivers of thepotential for an increase in the risk of suicidal thoughts or behaviors sothat patients may be closely observed.The FDA's actions are based on the agency's review of 199 clinical trials of11 antiepileptic drugs which showed that patients receiving antiepilepticdrugs had almost twice the risk of suicidal behavior or thoughts (0.43percent) compared to patients receiving a placebo (0.24 percent). Thisdifference was about one additional case of suicidal thoughts or behaviorsfor every 500 patients treated with antiepileptic drugs instead of placebo.Four of the patients who were randomized to receive one of the antiepilepticdrugs committed suicide, whereas none of the patients in the placebo groupdid. Results were insufficient for any conclusion to be drawn about thedrugs' effects on completed suicides. The biological reasons for theincrease in the risk for suicidal thoughts and behavior observed in patientsbeing treated with antiepileptic drugs are unknown.The FDA alerted health care professionals in January 2008 that clinicaltrials of drugs to treat epilepsy showed increased risk of suicidal thoughtsand actions. In July 2008, the FDA held a public meeting to discuss the datawith a committee of independent advisors. At that meeting the committeeagreed with the FDA's findings that there is an increased risk ofsuicidality with the analyzed antiepileptic drugs, and that appropriatewarnings should extend to the whole class of medications. The panel alsoconsidered whether the drugs should be labeled with a boxed warning, theFDA's strongest warning. The advisers recommended against a boxed warningand instead recommended that a warning of a different type be added to thelabeling and that a Medication Guide be developed.Acting under the authorities of the Food and Drug Administration AmendmentsAct of 2007 (FDAAA), the FDA is requiring manufacturers of antiepilepticdrugs to submit to the agency new labeling within 30 days, or provide areason why they do not believe such labeling changes are necessary. In casesof non-compliance, FDAAA provides strict timelines for resolving the issueand allows the agency to initiate an enforcement action if necessary.The following antiepileptic drugs are required to add warnings about therisk of suicidality:Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)Clonazepam (marketed as Klonopin)Clorazepate (marketed as Tranxene)Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)Ethosuximide (marketed as Zarontin)Ethotoin (marketed as Peganone)Felbamate (marketed as Felbatol)Gabapentin (marketed as Neurontin)Lamotrigine (marketed as Lamictal)Lacosamide (marketed as Vimpat)Levetiracetam (marketed as Keppra)Mephenytoin (marketed as Mesantoin)Methosuximide (marketed as Celontin)Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as DilantinSuspension)Pregabalin (marketed as Lyrica)Primidone (marketed as Mysoline)Tiagabine (marketed as Gabitril)Topiramate (marketed as Topamax)Trimethadione (marketed as Tridione)Zonisamide (marketed as Zonegran)Some of these medications are also available as generics.Health care professionals and consumers may report serious adverse events orproduct quality problems with the use of this product to the FDA's MedWatchAdverse Event Reporting program either online, by regular mail, fax orphone.-- Online : www.fda.gov/MedWatch/report.htm-- Regular Mail : use postage-paid FDA form 3500 available at:www.fda.gov/MedWatch/getforms.htmand mail to MedWatch, 5600 Fishers Lane , Rockville , MD 20852-9787-- Fax: (800) FDA-0178-- Phone: (800) FDA-1088For more informationInformation for Health Care Professionals and Public Health Advisory:http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm_____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. 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