FDA Keeps Avandia on the Market
Arthur Moss, M.D., director of the Heart Research Follow-up Program, and David Oakes, Ph.D., professor of Biostatistics, participated on an FDA panel that recommended that the controversial diabetes drug Avandia remain on the market as an option for physicians treating patients with Type 2 diabetes.
The special scientific advisory panel was convened in July to provide recommendations on Avandia, which some studies have shown increases cardiac risks for patients.
Based on the existing research, Moss said, “There are risks but they are quite small and not necessarily out of proportion to other drugs on the market.”
Moss and Oakes agreed that the data presented throughout the two-day advisory committee meeting was weak and inconclusive, and that a head-to-head trial directly comparing Avandia with rival Actos and older diabetes drugs is needed to determine if one drug is superior to the other in terms of safety and efficacy.
“Diabetes is an enormous problem for individuals and public health generally,” Oakes added. “Although we have many therapies, there is no ideal therapy and it is important that research in this area continue.”
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