FDA Asks For Warning For Epilepsy Drugs

Armen Hareyan's picture

FDA is going to request a 'black box' warning for all epilepsy drugs, because of the risk for suicidal thoughts and inadequate behavior.

An advisory panel of outside experts will discuss the request from FDA on Thursday about the black box warning, which is the strongest warning ever. FDA asks for the warning on every single epilepsy drug, even on those which did not reported any risk yet.


FDA came to this request after last month's study of several epilepsy drugs, which found that only 3 out of 11 examined epilepsy drugs did not show serious adverse side effects. However, even these 3 drugs were found suspicious, because the way drugs work can later lead to behavioral problems.

"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)," said Dr. Russell Katz from FDA.

Epilepsy drug making companies respond to the request saying that their drugs already carry warning labels about adverse side effects, but the companies are ready to conduct further researches and put black box warnings on if necessary. Some of companies will also present additional research data on Thursday meeting.

According to latest statistics, there are about 2.7 million Americans suffering from epilepsy and these people spend billions of dollars on drugs to cut seizure risk. Among top selling epilepsy drugs are GlaxoSmithKline's Lamictal, Pfizer's Lyrica, Johnson & Johnson's Topamax, and Abbott Laboratories's Depakote. Lamictal sales in 2007 accounted for $2.2 billion and Lyrica sales accounted for $1.8 billion.