FDA Announces Intention to Seek Black Box Warnings on Epilepsy Drugs

By Aaron Poehler

Published on July 08, 2008

The U.S. Food and Drug Administration announced Monday that they intend to ask drug manufacturers to add warnings about increased suicide risks to 11 drugs used to treat epilepsy.

The proposed warnings would be 'black box' warnings, which indicate that medical studies have shown that the labeled drug carries a risk of serious adverse side effects. 'Black box' warnings are the most serious warnings issued by the FDA.

An FDA analysis of epilepsy drugs released earlier this year showed that patients taking anti-seizure medications were around twice as likely to have suicidal thoughts and behaviors. Although three of the 11 drugs studied did not indicate an increased risk of suicidal problems, the proposed warning label would apply to all epilepsy drugs.

Among the drugs which would be newly labeled under the proposal are Lyrica, Gabitril, Trileptal, Lamictal, Topamax, Depakote, Tegretol, Felbatol, Neurontin, Keppra, and Zonegran; the affected drugs sold a combined total of over $8 billion last year. While around 2.7 million Americans have epilepsy, anti-seizure drugs are widely used to treat a variety of conditions including chronic pain, migraine headaches, and bipolar disorder. A panel of outside medical experts is expected to discuss and comment on the proposed warnings at an FDA-sponsored public meeting on Thursday. Drug manufacturers including GlaxoSmithKline Plc, manufacturer of Lamictal, are also expected to comment upon the proposal at that time.