FDA Panel to Reconsider Restrictions on Diabetes Drug AvandiaJun 3, 2013
A panel of experts will meet this week to advise the U.S. Food and Drug Administration (FDA) in its reconsideration of restrictions placed on the diabetes drug Avandia (rosiglitazone).
In 2010 the FDA announced significant restrictions on Avandia (rosiglitazone) use, in response to studies suggesting there was an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia. In 2011 the FDA further tightened the restrictions, requiring healthcare providers and patients to enroll in a special program in order receive rosiglitazone medications. After November 18, 2011, these medications were no longer available through retail pharmacies.
Rosiglitazone is sold as a single-ingredient product, manufactured by GlaxoSmithKline under the brand name Avandia; it is also an ingredient in Avandamet (which contains rosiglitazone and metformin) and Avandaryl (which contains rosiglitazone and glimepiride).
Because of the heart risks, European regulators removed Avandia from the market in 2010, the same year the FDA restricted its use in the United States, The New York Times reports. Dr. Janet Woodcock, the FDA’s top drug official ordered an outside review of Glaxo’s six-year clinical trial, which published its results in 2009. Duke University researchers conducted the review and they found previously unreported cases of heart complications and deaths, though, according to Glaxo, these findings were not enough to change the conclusion that Avandia did not significantly raise the risk of cardiovascular harm, the Times reports.
Some outside experts say the Glaxo trial was seriously flawed, while others question the independence of the Duke review, which Glaxo paid for. Dr. Woodcock told the Times: “What we’re trying to do here is resolve that uncertainty as much as we can with all the available data.”
About 26 million Americans have diabetes, and patients spent $22 billion on diabetes medications in 2012, The New York Times reports.