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An FDA advisory committee will review whether to recommend withdrawing the antidiabetic drug rosiglitazone (Avandia) from the U.S. market because of cardiovascular risks.
On July 13 and 14, the committee will also consider whether to recommend halting or altering an ongoing manufacturer-sponsored postmarketing trial of rosiglitazone's safety that the FDA mandated in 2007. The trial aims to compare the cardiovascular safety of rosiglitazone with that of placebo and of pioglitazone (the other thiazolidinedione on the market).
The review was prompted by new data from other recent trials, including RECORD. The drug's manufacturer says RECORD shows concerns about the cardiovascular risk are overblown and limited to heart failure risk. Others, including one FDA reviewer, contend the RECORD trial was conducted improperly and actually supported the risks suggested by previous studies.
The New York Times and AP report the issue as an ongoing test of the FDA's ability to ensure drug safety.
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LINK(S):
FDA advisory panel briefing materials (Free)
New York Times story (Free)
Associated Press story (Free)
Physician's First Watch coverage of the RECORD trial (Free)