For a long time now, it's looked like the FDA was gearing up toward putting a black-box warning on epilepsy drugs, since it was discovered that they can potentially increase the risk of suicidal thoughts and behaviors in patients who take them. However, in a surprise move, an FDA-convened panel has ruled 14-4 against imposing a black-box warning on this class of drugs, which includes Pfizer's Lyrica and Johnson & Johnson's Topamax. The committee concluded that though the risks were real, they weren't high enough to merit a black-box warning. And some panel members noted that imposing a black-box on epilepsy drugs might discourage some patients from taking them, even when the merits of the drug outweigh these risks. Instead of recommending the black-box warning, the panel is suggesting that the FDA send a medication guide to doctors outlining the drugs' risks.
To learn more about the FDA panel's decision:
- read this Wall Street Journal blog item
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