Tuesday, November 25, 2008

No Black Box for Antiepileptics

It looks like the Food & Drug Administration will be requiring consumer medication guides and new warning language regarding the risk of suicidality associated with anti-seizure medications--but not a full-fledged "black box" warning.

The agency hasn't announced anything official on that score, but it has quietly adopted the new approach in the context of two recent approvals for new anti-seizure medicines. In case you missed it, "The Pink Sheet" has the full story.

An FDA advisory committee recomended against a black box warning in July. But in the current drug safety climate, and especially given the politically charged interest in suicidality associated with a whole host of products, it looked like a close call whether the agency would in fact follow that advice.

That sounds like good news for some big brands, including Pfizer's Lyrica, J&J's Topomax and Cephalon's Gabitril. (Click here to see all the products affected by the safety review.)

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