Feds Propose to Black Box Epilepsy Drugs

Jul 10, 2008
By Pharmaceutical Executive Editors

FDA has officially proposed adding black box warnings to 11 epilepsy drugs documenting the increase of suicidality in patients taking the medication. The proposal stems from a review of 200 studies in which patients taking epilepsy meds were more likely to suffer from depression and have suicidal thoughts than those not taking the treatment.

"There seems to be no compelling reason to ignore what appears to be a very clear, empirical finding of increase in suicidality, despite no obvious explanation," said Rusty Katz, FDA director of neuropharmacological drug division, in a release.

The Epilepsy Foundation begs to differ.

A representative for the organization will provide testimony at an advisory committee meeting scheduled for later today asking the committee to reconsider the black box warnings in favor of further studies on the specific causes of the suicidal ideation. According to the foundation, there is research that suggests that depression and epilepsy have a common underlying physiological cause.

"You have to address the issues around co-morbid conditions such as depression," said Eric Hargis, president and CEO of the Epilepsy Foundation. "Is the problem the AED [antiepileptic drug] or is the problem a mood disorder."

Hargis is worried that by rushing to add a black box warning to epilepsy meds, physicians might switch patients to another treatment, or eschew a better drug with a warning in favor of an inferior treatment without a warning.

"We are concerned that there may be reluctance among physicians to try different treatment options if one treatment has a black box warning, and that might not be the right treatment option for that patient," Hargis told Pharm Exec on Wednesday.

The foundation notes that people with depression are more likely to have epilepsy and vice versa, which suggests that there might be a common basis between epilepsy and suicide.

"FDA is only looking at AED's, and not at the existence or absence of co-morbid conditions," Hargis said. "The question is what causes suicidality—is it the drugs or other medical conditions?"

The Epilepsy Foundation said it had not been contacted by FDA to work with them on the proposal, and the organization was disappointed to find out about the warnings at the same time it was announced to the public.

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