FDA Calling for Warnings on Epilepsy Medication

Posted on behalf of Jeff Pitman on October 5, 2008 in Press Releases
Updated on February 24, 2022

The U.S. Food and Drug Administration will seek to include strong warnings about suicidal behavior on the labels of 11 epilepsy drugs, according to documents posted on the agency’s Web site.

The FDA will ask companies to update labels for the drugs, including Pfizer Inc.’s Lyrica, with black-box warnings, the most serious warnings the agency issues. Sales of the affected drugs, widely used for other problems such as chronic pain, were more than $8 billion last year. A committee of outside medical experts discussed suicidal behavior associated with epilepsy drugs at an FDA-sponsored meeting last month.

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In June, the agency said it was finalizing plans to include language warning about suicidal behavior on the drugs’ labels after saying studies show statistically significant differences in suicidal tendencies for patients who have taken the drugs. It was unclear at the time whether the agency would seek black-box warnings. An updated label warning about suicidal behavior would likely affect Pfizer more than any other company. Its epilepsy drug, Lyrica, is relatively new to the market and brought in $1.8 billion in sales in 2007. Pfizer has disputed the FDA’s data, saying its own information shows Lyrica isn’t associated with a risk for suicidal behavior. Other drugs whose labels may be updated are Cephalon Inc.’s Gabitril and Novartis AG’s Trileptal.

Source: Wall Street Journal

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