Thursday, June 7, 2007


FDA Asks for Black-Box Warning on Heart Failure Risk with Glitazones

In Congressional testimony yesterday, the FDA commissioner revealed that the agency has requested that the manufacturers of rosiglitazone (Avandia) and pioglitazone (Actos) add black-box warnings about the risk for heart failure with these drugs.

The commissioner indicated that the request was made because although the drugs currently carry warnings about potential heart failure, they are still sometimes prescribed to patients with this condition.

The request was only made public yesterday but was made to the companies on May 23, a couple of days after the publication of a meta-analysis that raised questions about the potential risk for heart attacks with rosiglitazone. The manufacturers have indicated that they are in negotiations with the agency over the new warnings.

Link: New York Times story (One-time registration required)

Link: Wall Street Journal story (Subscription required)

Link: Physician's First Watch coverage of interim analysis (Free)

Published in Physician's First Watch June 7, 2007

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