FDA Questions Avandia Restrictions

The FDA has decided to revisit the once controversial case regarding Avandia (rosiglitazone; GlaxoSmithKline), and will ask upon an expert advisory panel whether the agency must reconsider the restrictions on Avandia.

Avandia is a thiazolidinedione indicated as adjunct to diet and exercise in type 2 diabetes, as monotherapy, or in combination with metformin and/or a sulfonylurea.

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In 2010, the FDA announced a significant restriction on the use of Avandia in response to data that suggested an elevated risk of cardiovascular events (eg, heart attack and stroke) in patients treated with Avandia. The agency required GlaxoSmithKline to develop a restricted access program under a Risk Evaluation and Mitigation Strategy (REMS) program. This REMS allowed Avandia to be available to new patients only if they were unable to achieve glucose control on other antidiabetic agents and were unable to take Actos (pioglitazone; Takeda).

In addition, GlaxoSmithKline was ordered to convene an independent group of scientists to review the RECORD trial, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs.

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It is this trial that experts are being asked to consider later this week. A preliminary summary of the recent analysis conducted by Duke researchers states that unreported cases of cardiovascular complications and deaths have been found, but they still support GlaxoSmithKline’s original findings that suggest Avandia is as safe as older antidiabetic agents.

The expert panel will be voting on four options for Avandia: (1) remove Avandia’s safety restrictions, (2) leave the safety restrictions in place, (3) modify the safety restrictions, or (4) withdraw the drug from the market.

The Endocrinilogic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will be holding the joint meeting on June 5–6, 2013.

For more information call (800) 741-8138 or visit the FDA website


Which action should the FDA take with Avandia’s safety restrictions?