The FDA panel voted 14 to 4 with three abstentions against adding the tougher warning, saying that a strong warning could scare epilepsy patients from being treated with effective drugs. However, the panel voted in favor of sending a medication guide to doctors detailing the risks of suicide with the drugs.
In late January, the FDA announced it was considering a black box warning after an agency review of 199 studies found that patients taking the drugs had about twice the risk of suicidal behavior compared with patients taking a placebo.
A black-box warning, which typically appears at the top of drug labels, is in bold type and is surrounded by a black border to make it stand out. It typically appears at the top of drug labels.
Pfizer Inc. and GlaxoSmithKline Plc are the largest suppliers of epilepsy drugs. The move could be a boon to the $8 billion-plus epilepsy drug industry.
More than 10 million Americans took FDA-approved epilepsy drugs in 2007.
