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FDA Finally Takes Action on Avandia

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Finally, the US Food & Drug Administration (FDA) has made its long-awaited decision on Avandia. It’s not yanking Avandia from the market, but the agency is making the controversial diabetes drug more difficult to get.

Under new restrictions announced today, patients in the US will only have access to Avandia if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of Avandia’s cardiac side effects. The restrictions also apply to Avandamet and Avandaryl.

“Because of concerns about cardiovascular safety, FDA is announcing regulatory action on medications containing rosiglitazone,” FDA Commissioner Dr. Margaret A. Hamburg said during a morning press conference. “FDA is significantly restricting the use of these products by requiring the manufacturer to submit a Risk Evaluation and Mitigation Strategy [REMS].”

The FDA also ordered GlaxoSmithKline to convene a group of independent specialists to review “important concerns” about “potential bias” in a long-term safety study of Avandia known as RECORD. The widely criticized RECORD study, which was released in 2009, did not find increased heart risks, as other Avandia studies have. It was touted by Glaxo as evidence of the drug’s safety.

In Europe, the news was even worse for Avandia, as regulators there suspended marketing of the drug altogether. The suspension will remain in place unless there is new data showing that the benefits of the drug outweigh its risks.

According to the Associated Press, GlaxoSmithKline’s chief medical officer, Dr. Ellen Strahlman, said in a statement that the company will voluntarily stop promoting Avandia in all countries where it operates.

Since November 2007, Avandia’s label has included a black box warning – the FDA’s strongest safety alert – detailing its association with myocardial ischemia. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. Since the addition of the black box, evidence linking Avandia to an increased risk of heart attacks has continued to accumulate.

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