FDA Wants Black Box Warning On Epilepsy Drugs

FDA Wants Black Box Warning On Epilepsy DrugsThe U.S. Food and Drug Administration wants a “black box” warning about increased suicide risks on all epilepsy drugs. The agency wants the warning even on epilepsy drugs that have showed no risk signal.

"We are going to ask for a boxed warning on these drugs," FDA spokeswoman Sandy Walsh said on Monday. The proposal has been released ahead of a meeting to be held on Thursday in which a panel of outside experts will identify the drugs possible risks to users.  

The FDA said that though three of the 11 drugs showed no clear signal of suicidal problems their analysis of nearly 200 patients showed an increase in suicidal thoughts of patients who took anti-seizure drugs as compared to those who took placebos. The top selling epilepsy drugs are GlaxoSmithKline Plc's Lamictal, Pfizer Inc's Lyrica, Johnson & Johnson's Topamax, and Abbott Laboratories Inc's Depakote.

Dr. Russell Katz, head of the FDA's division of neurology products felt there were reasons to justify the need for the black box warning such as statistical chance, sample size and the specific way each particular drug works.

"There seems to be no compelling reason to: 1) ignore what appears to be a very clear empirical finding of an increase in suicidality, despite no obvious explanation for this finding, or 2) not generalize the conclusion to other (anti-epilepsy drugs)," Katz wrote.

According to government estimates, about 2.7 million Americans have epilepsy, and anti-seizure drugs are used for a number of illnesses including epilepsy, from migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder.