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FDA Restricts Avandia in U.S. while EMA Recommends Suspension of European Sales

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September 23, 2010

The U.S. Food and Drug Administration (FDA) announced today that the agency is significantly restricting the use of the diabetes drug Avandia (rosiglitazone) due to data that suggests an elevated risk of cardiovascular events, such as heart attack and stroke with Avandia use.

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care.”

Rosiglitazone also is available in the U.S. in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

The FDA will require that GlaxoSmithKline (GSK) develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Patients currently taking Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Physicians will have to attest to and document their patients’ eligibility for Avandia use and patients will have to acknowledge they understand the cardiovascular risks with Avandia.

“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The European Medicines Agency (EMA) today recommended the suspension of Avandia and Avandia-containing Avandamet and Avaglim sales in Europe and that patients currently taking the drug should discuss alternative treatment with their doctor because the drug will no longer be available within the next few months. The recommendation now goes to the European Commission for the adoption of a legally binding decision.

“Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients,” GSK said in a statement.