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REMS no longer needed for medicines containing rosiglitazone

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The FDA today announced that it is eliminating the Risk Evaluation and Mitigation Strategy for rosiglitazone-containing type 2 diabetes medications.

The Risk Evaluation and Mitigation Strategy (REMS) is no longer needed to ensure that benefits of the medications outweigh risks. Approved medications include Avandia (rosiglitazone, GlaxoSmithKline), Avandamet (metformin hydrochloride/rosiglitazone maleate, GlaxoSmithKline), Avandaryl (rosiglitazone maleate and glimepiride, GlaxoSmithKline) and generics.

The FDA dropped some prescribing and dispensing restrictions related to the REMS in 2013 after determining that data did not support an increased risk for heart attack with rosiglitazone compared with metformin and sulfonylureas. The FDA has now concluded that drug manufacturers have fulfilled a requirement to provide educational training for health care providers regarding possible risks involved with medications containing rosiglitizone.

No new pertinent safety information is available, and the FDA continues to monitor the medications.