Posted: 07-13-10 Categories:
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FDA opens hearings to evaluate Avandia safety, vote on recall

If Avandia use causes increased cardiovascular risks compared to rival diabetes drug Actos, should the FDA recall Avandia? Would adding a new warning label and package insert be sufficient? What should doctors and diabetes patients think about Avandia in light of the controversy surrounding its safety?

These are some of the questions faced by a panel of experts at a joint FDA drug advisory committee meeting taking place today and tomorrow. The panelists, members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee and the FDA Drug Safety and Risk Management Advisory Committee could vote tomorrow (July 14, 2010) in favor of an Avandia recall.

FDA Commissioner Margaret Hamburg offered the following advice to the committee members, “…keep an open mind, apply your sharpest scientific thinking and use your best judgment.” “Follow the science wherever it leads and the rest will fall into place,” she said. She told the panelists that they would be in for “a very interesting two days.”

Among the witnesses to testify today was renowned Cleveland Clinic cardiologist Dr. Steven Nissen, a longtime Avandia critic and author of a 2007 study published in the New England Journal of Medicine that found Avandia users had a 43% higher risk of heart attacks compared to patients who used other diabetes drugs.

“In an unfortunate mistake neither GSK nor FDA made any public statement warning physicians of the finding [of heart risk],” Dr. Nissen testified. “We didn’t know.”


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