Avandia Black Box Warning

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What’s the problem? On November 14, 2007, the FDA announced in a press release that the diabetes drug Avandia (generic: Rosiglitazone) was to receive new information in the black box warning that was already in place on the drug’s label. The updated information included warnings that Avandia may cause heart attacks.This announcement followed a study that concluded that the drug may increase the risk of fatal heart attacks in people who use the drug.

The “black box” warning is the strongest warning that the FDA adds to labels on medications that may pose a health threat to users. Both rosiglitazone and pioglitazone are thiazolidinediones. Avandamet is a combination drug composed of rosiglitazone and metformin and Avandaryl is a combination of rosiglitazone and glimepiride. Avandia, Actos, Avandamet, and Avandaryl received black box warnings about increased risks of congestive heart failure in August of 2007, following the New England Journal of Medicines article covering the results of the Meta Study that implicated rosiglitazone as causing fatal cardiovascular events.

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