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FDA Panel Advises Against Black Box Warning on Epilepsy Drugs

Posted by Chrissie Cole
Thursday, July 10, 2008 11:11 PM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Epilepsy, Dangerous Drugs, Suicidal Behavior


A U.S. advisory panel is not in favor of adding a “black box” warning to labels of anti-seizure drugs used in the treatment of epilepsy. While epilepsy drugs do carry an increased risk of suicidal thoughts and ideation, the panel says studies didn’t show a high-enough risk to justify the agency’s toughest warning.

Members of the Food and Drug Administration’s (FDA) panel of outside experts denied the agency’s suggested caution, communicating concern that adding strong warnings could potentially make epilepsy patients apprehensive about being treated effectively with drugs.

The FDA will have the final say, but the agency typically follows recommendations made by the advisory panel.

In 2007, more than 10 million Americans took FDA-approved epilepsy drugs.

Fourteen panel members voted against adding a black box warning, while four members were in favor of the proposed label change and three abstained. The panel did, however, vote in favor of sending a medication guide to physicians highlighting the increased risk of suicide in some patients.

The FDA had requested a black-box warning be added to more than ten different epilepsy drugs after studies showed that in some patients, use lead to risk of suicidal thoughts and behavior.

A black box warning is printed in bold type and surrounded by a “black box” so that it stands out amongst the other text on the label. Typically, the warning appears at the top of drug labels. When drug companies advertise products that carry a black box warning, they also must include the warning information as part of the advertisement.

While the panel didn’t feel the risk was steep enough to warrant a black box warning, several members agree there is a serious need for physicians to communicate the increased risk of suicidal thoughts and behavior with their patients using such medications.

An epileptic has recurring seizures that are caused by irregular electrical impulses in the brain. When the cause of epileptic seizures cannot be determined, certain anti-seizure drugs may be prescribed to control their occurrence. #

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