The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (FDA) is informing the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs.
The new restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS)—a program FDA may require to manage serious risks of marketed drugs. The restrictions are based on data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone. The decision to restrict access to rosiglitazone medicines was made on September 23, 2010.
FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products.
For more information, please visit: Rosiglitazone REMS
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