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Epilepsy Health Center

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FDA Panel: No Warning on Epilepsy Drugs

Advisory Panel Rejects 'Black Box' Warnings of Suicide Risk

Controversy Over Warnings continued...

Critics blamed the warnings for driving some patients away from needed treatment, and the agency later revised its warnings.

Some experts worried Thursday that the agency was going down a similar road, making blanket warnings for drugs that have not necessarily been studied or analyzed for suicide risk.

"We have to be very careful about scaring the patients into not taking these drugs, and I think we have to be very thoughtful about that," says Rochelle Caplan, MD, a professor of psychiatry at University of California Los Angeles and a member of the expert panel.

That was echoed by manufacturers, who maintained their drugs did not increase the risk of suicide.

"Overwarning actually has the potential to negatively impact patient care," says Christopher Wholberg, a global medical team leader for Pfizer, which makes Lyrica and Neurontin.

Researchers aren't sure what causes the apparent link between epilepsy drugs and suicidal thought and behavior. While depression is common in people suffering from epilepsy and seizures, many subjects in the trials were using the drugs for problems other than epilepsy. Some used the drugs for nonpsychiatric uses.

"We don't quite know what the phenomenon we're looking at is," says Robert Temple, MD, director of the FDA's office of drug evaluation. Still, officials said they were persuaded that their analysis warranted new black box warnings.

"If something is important it gets noticed better if you put a box around it. It doesn't mean don't use this drug. It means pay attention," Temple says.

But the FDA's advisors declined to recommend black box warnings for the drugs, saying there was not enough evidence to support stark warnings that could discourage patients and their doctors from using them.

"That's put there to bring attention to it and it comes with a lot of baggage with it," says Larry Goldstein, MD, a professor of Medicine at Duke University and chair of the advisory panel.

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