FDA panel opposes "black box" warning for epilepsy drugs

07/10/2008 | Wall Street Journal, The · San Diego Union-Tribune

An FDA advisory panel recommended against including a "black box" warning about the risk of suicidal behavior on the packaging of anti-seizure medications. Panel members voted in favor of providing medical practitioners with a medication guide explaining such risks. A Pfizer official said the labeling for Lyrica and Neurontin correctly shows their risk and benefit profiles, while a GlaxoSmithKline executive said the company thinks Lamictal's label should carry more suicide-risk data.

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Wall Street Journal, The · San Diego Union-Tribune

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