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Risk Evaluation and Mitigation Strategy No Longer Necessary for Rosiglitazone-Containing Diabetes Drugs
The FDA has eliminated the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines (Avandia, Avandamet, Avandaryl, and generics) as it is no longer necessary to ensure that the benefits of the medicines outweigh their risks.
In 2013, the FDA required removal of the prescribing and dispensing restrictions for these medicines after determining that data did not demonstrate an increased risk of heart attack with rosiglitazone medicines compared to standard type 2 diabetes medicines.
The FDA also required the drug manufacturers to provide educational training to health care professionals about the current state of knowledge regarding the heart risks of rosiglitazone medicines.
The FDA says that after monitoring these medicines no new pertinent safety information has been identified.
