FDA Panel Recommends Against Epilepsy Drug Black Box Warning

The U.S. Food and Drug Administration (FDA) convened an advisory panel last week to evaluate the risk of suicide associated with epilepsy drugs, and to make recommendations about what regulatory actions should be taken to protect consumers. Although FDA officials indicated they believe a “black box” warning should be placed on the drugs, the independent panel recommended against such a strong warning at a hearing on July 10, 2008.

FDA advisory panels consist of external medical experts who are brought together by the agency to provide advice and recommendations. Although the FDA is not bound by the recommendations of their advisor panels, they usually do follow their advice.

The panel was convened after an FDA analysis released in January 2008 identified an increased risk of suicidal thoughts and behavior among users of the epileptic drugs. Data revealed that the anti-seizure medications increased the risk from .22% to .43%, which implies an additional 2 suicides could occur for every 1,000 people taking the drugs.

According to government estimates, nearly 2.7 million Americans suffer from epilepsy, which is a neurological disorder characterized by chronic unprovoked seizures. In 2007, anti-seizure drugs generated sales of over $10 billion, making them the fifth best-selling class of drugs in the United States. GlaxoSmithKline’s Lamictal, Pfizer’s Lyrica and Abbott’s Depakote are some of the top sellers.
 
The FDA advisory panel did find that the epilepsy drugs carry an increased suicide risk, but did not believe a “black box” warning is necessary. A “black box” warning is the strongest available warning that can be placed on a prescription medication, and it is prominently featured with a black border to draw attention to the seriousness of the risk.

The panel concluded that the risk of suicide was relatively low and there was not enough evidence to justify the use of the FDA’s toughest warning. They suggested that a “black box” warning could scare consumers into not taking their medication, which has been shown to be effective in treating epilepsy. It could also cause doctors to be reluctant in prescribing the drugs.