Skip to main content

FDA panel votes against black box warnings for epilepsy drugs


WASHINGTON An advisory group for the Food and Drug Administration voted 14-4 against adding a black-box warning about the risks of suicidal tendencies to all anti-seizure drugs, according to Reuters. The experts said they worried the warning labels could inadvertently cause doctors and patients to abandon the treatments.

The agency had announced plans early last week to add the warning to epilepsy drugs, in light of higher rates of suicidal tendencies seen across dozen of studies. Instead of a boxed warning, a majority of panelists said companies should distribute pamphlets about the drugs’ risks to patients.

Drugs included are: Pfizer’s Lyrica and Neurontin, GlaxoSmithKline’s Lamictal, Johnson & Johnson’s Topamax and UCB Inc’s Keppra, among others. These medications brought in more than $10 billion in 2007 sales, according to IMS Health.

Pfizer vice president Steven Romano said he was pleased with the panel’s vote against a boxed warning label. Earlier in the day, Pfizer had argued that Lyrica worked differently than rival epilepsy medications and should not be subject to the warning favored by the FDA. Competitor GSK though approved of the regulators’ plans, saying suicide concerns should be added to all drugs’ labeling.

More than 10 million Americans take the anti-seizure medications, which are also used to treat migraines, certain nerve-pain disorders such and psychiatric diseases as bipolar disorder.

The FDA said it would make a decision on the warnings “soon,” but did not specify a date.

This ad will auto-close in 10 seconds