Endocrine Insider
March 4, 2010

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Last month the Senate Finance Committee issued a report to the FDA detailing concerns about the safety of rosiglitazone (Avandia). This report came as a result of an inquiry into the drug that began after the release of a 2007 study published in the New England Journal of Medicine on the cardiovascular effects of rosiglitazone.

In response to the Senate Finance Committee’s report, The Endocrine Society released a statement urging the FDA to re-convene its Endocrinologic and Metabolic Drugs Advisory Committee to examine the safety and efficacy of the drug. In the statement, the Society also recommends that physicians discuss with each patient taking rosiglitazone both the safety issues that have been raised with the use of this drug and the risk/benefit of its continued use.

On February 22, Dr. Vigersky participated on a call with the FDA to discuss the safety concerns surrounding Avandia. The FDA agreed to re-convene its Endocrinologic and Metabolic Drugs Advisory Committee in July 2010. Although Dr. Vigersky asked the FDA to consider re-convening the committee earlier, the FDA stated that there was too much data to analyze to hold the committee meeting any earlier than July.

Following the Society’s statement, reporters from U.S. News & World Report and The Wall Street Journal interviewed Dr. Vigersky.