An FDA advisory panel voted 20 to 12 to recommend that the agency allow rosiglitazone (Avandia, GlaxoSmithKline) to remain on the market.
An FDA advisory panel voted 20 to 12 to recommend that the agency allow rosiglitazone (Avandia, GlaxoSmithKline [GSK]) to remain on the market. However, according to various media reports, most panelists want to see tougher warnings on the diabetes drug's label. FDA usually follows the advice of its advisory committees, though it is not bound to do so.
The panel found that the data presented were sufficient to raise significant safety concerns for heart risk in patients with type 2 diabetes when rosiglitazone was compared with other diabetes treatments. Steven Nissen, MD, a Cleveland Clinic cardiologist, first raised this concern after analyzing numerous studies of rosiglitazone in 2007.
Only 3 of the panel members who voted for rosiglitazone to stay on the market thought that current product labeling was sufficient.
The 12 panelists voting to take the drug off the market argued that there is no need for rosiglitazone when patients can take pioglitazone (Actos, Takeda), which has not been found to present excess ischemic events. By a vote of 21 to 4 (with 8 members unable to decide), panel members affirmed that rosiglitazone is less safe than pioglitazone.
The committee reached its decision after 2 days of presentations and discussions on GSK's trial data.
In a statement following the panel's decision, GSK said that it will continue to work with FDA. "We remain fully committed to maintaining best practice disclosure of clinical data to serve the interests of regulators, physicians, and patients," said Ellen Strahlman, MD, chief medical officer of GSK.
Janet Woodcock, MD, director of the Center for Drug Evaluation and Research for FDA, said a decision will be made as soon as possible.
Ken Krizner is a freelance writer and editor based in the Cleveland area.