FDA seeks suicide warning on anti-seizure drugs

In materials posted online Monday, FDA scientists proposed adding a "black box" warning about suicide risks to all drugs used to treat seizures. The agency released the proposal ahead of a meeting Thursday, where outside experts will weigh-in on the drugs' risks.

FDA said in January its analysis of nearly 200 studies showed patients taking anti-seizure drugs were more likely to have suicidal thoughts and behaviors than those taking dummy pills. While the reported problems were extremely rare, FDA found drug-treated patients did face about twice the risk. On average, those patients experienced suicidal thoughts or behavior 0.43 percent of the time, compared with 0.22 percent of those taking dummy pills.

FDA scientists said they are determined to move forward with revised warning labels for all drugs in the class, although it is not entirely understood why they increase suicidal behaviors.

"There seems to be no compelling reason to ignore what appears to be a very clear empirical finding of increase in suicidality, despite no obvious explanation," states FDA Director of Neurology Products Russell Katz, in the briefing documents posted online.

Katz and other FDA scientists will suggest Thursday that patients be given a pamphlet about suicide risks each time they fill a prescription for one of the drugs. A panel of outside experts is expected to comment on that idea, as well as the proposed black box warning label. FDA is not required to follow the panel's advise, though it usually does.

Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder.

Seizure drugs were the fifth best-selling class of drugs in the U.S. last year, with sales over $10 billion, according to pharmaceutical research firm IMS Health.

GlaxoSmithKline's Lamictal posted sales of $2.2 billion for 2007, while Pfizer's Lyrica had sales of $1.8 billion.

Doctors who prescribe the medications have been urging FDA to take a measured approach to any new warnings, arguing they could cause more harm than good if patients to stop taking the drugs completely.