Avandia to Receive New Black Box Warning

Wednesday November 14, 2007

The FDA announced, in a press release November 14th, that the diabetes drug rosiglitazone (Avandia) will receive new information in the black box warning that is already in place on the drug's label. The updated information will include warnings that rosiglitazone may cause heart attacks. This follows the recent study that concluded that Avandia 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.

Although the FDA found the results of the Meta Study to be inconclusive, GlaxoSmithKline, the company that manufactures Avandia, has been asked to conduct a new study to investigate how much of a cardiovascular risk exists for the drug.

Read the New England Journal of Medicine's original article on the Meta Study...