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Advisory Panel Rejects 'Black Box' Warnings of Suicide Risk on Epilepsy Drugs

Jul 11, 2008 | Parker Waichman LLP An expert advisory panel refused a Food & Drug Administration (FDA) proposal to place a “Black Box”—the agency’s strongest warning—warning about suicide risks on 11 common epilepsy drugs, including Neurontin, Lyrica, and Topamax.  All the drugs cited are approved to treat epilepsy, but many are prescribed for other problems, including migraines and bipolar disorder. The FDA often follows the recommendations of its advisory panel, but is not required to.

Following an FDA analysis of some 200 studies, it concluded patients taking the epilepsy drugs had nearly double the risk of suicidal thoughts or behaviors.  Earlier this week, FDA officials proposed inclusion of the black box to force companies to issue new medication guides warning patients of potential risks.  Eight of the 11 drugs showed an increased risk, while three did not; however, the FDA is proposing warnings on all of the drugs and possibly some older epilepsy drugs. Other drugs include Lamictal, valproate, oxcarbazepine (sold under the brand name Trileptal), Tegretol, tiagabine, zonisamide, levitiracetam, and felbamate.  Of the 43,000 patients studied, 30 taking epilepsy drugs attempted suicide and four completed suicide.

Experts continue to urge the FDA to place some type of new warnings on the drugs.  "We are looking at a signal that I feel is an important one for the field to be aware of," says Andrew Winokur, MD, a professor of psychiatry and psychopharmacology at the University of Connecticut Health Center.

The FDA’s proposal for a warning sparked controversy as soon as it was announced and the FDA was also criticized in 2005 after placing similar warnings on antidepressant medications when evidence suggested some of the drugs could lead to suicidal behavior.  FDA critics said the warnings drove patients away from necessary treatment.  The FDA later revised its warnings.

Some experts fear the FDA is making a similar move by suggesting broad warnings for drugs that may not have 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.  "Overwarning actually has the potential to negatively impact patient care," said Christopher Wholberg, a global medical team leader for Pfizer, which makes Lyrica and Neurontin.

Researchers remain unclear as to the cause of the link between epilepsy drugs and suicidal thought and behavior.  "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. "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.  FDA advisors disagreed, saying there was insufficient 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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