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FDA Panel Votes to Ease Safety Restrictions on Avandia

by Elizabeth Davis on June 13, 2013 at 10:21 am

Since 2010, use of diabetes med Avandia has been restricted to patients who weren’t able to control their diabetes using other medication options. Studies showed an increased risk of heart problems, and the manufacturer, GlaxoSmithKline, plead guilty and was fined for witholding safety information about Avandia.

On the panel that made the decision to restrict Avandia (rosiglitazone) in 2010, 12 out of 26 panelists voted to remove it from the market altogether. This time, 13 out of 26 voted to loosen restrictions and 7 voted to remove the restrictions completely. Five panelists voted to keep the current restrictions, and one to remove Avandia from the market completely.

Right now, Avandia has a black box warning, the strongest warning required by the FDA, indicating potentially life-threatening side effects. Any patients prescribed Avandia (and doctors prescribing) must sign up participate in a REMS (Risk Evaluation and Mitigation Strategies) program. This involves an agreement to participate in education, regular assessments, and evaluations of safe use.

The recent panel vote is advisory, so no decisions have been made by the FDA yet. The opinions of the panel—while mostly in favor of loosening restrictions—did vary on how much the restrictions should be relaxed. The FDA has discretion on how closely to follow the panel’s opinion, but it’s likely that some changes will be made.

This mean Avandia may be more readily available in the coming months or years, despite some known risks. It might also be good news for anyone from the small group (estimated to be just above 3,000 patients) currently taking Avandia. The patent expired in 2011, and a generic manufacturer does have approval to make generic rosiglitazone. They aren’t likely to move forward with the current restrictions and small pool of patients though, so a future generic might depend on the FDA loosening the restrictions and warnings.

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