June 19, 2013
Panel Recommends Keeping Avandia Available for
Washington, D.C.— A joint advisory committee to the FDA said the controversial diabetes drug Avandia should remain available to appropriate patients.
The majority of panel members, 20, on the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and the Risk Management Advisory Committee voted to either modify or remove the Risk Evaluation and Mitigation Strategy (REMS) program in place. Another five panel members voted to continue the REMS, while one member voted to withdraw the drug from the U.S. market.
While advisory panel votes usually are followed by the FDA, that may not be the case with Avandia because there was such a wide range of views on what should be done. The once blockbuster drug now is used by only a few thousand patients in the U.S.
Under the FDA's current REMS, Avandia can only be dispensed by specially licensed pharmacies. Also, physicians must sign a waiver stating that they understand the drug's risks and that their patients have not responded to any other diabetes medications.
The drug’s manufacturer, GlaxoSmithKline, said in a press release that the committee discussion overall reflected confidence in the integrity and reliability of the clinical study called RECORD—Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes. It noted that an independent re-examination of the trial was conducted by the Duke Clinical Research Institute and “confirmed the study’s original findings: that the risks of mortality and major adverse cardiac events with Avandia in combination with metformin or [sulfonylureas (SU)] are no different than with a combination of metformin and SU [without Avandia].”
James Shannon, MD, GSK’s Chief Medical Officer, said the company continues “to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labeling.”
In February 2010, a retrospective study, published in the Journal of the American Medical Association, concluded that rosiglitazone was associated with "an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI, stroke, heart failure, or all-cause mortality in patients 65 years or older.” FDA action followed the study, which was led by David J. Graham, MD, MPH, the FDA’s associate director for the Science and Medicine Office of Surveillance and Epidemiology.
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