REMS Removed for Rosiglitazone Diabetes Drugs
REMS deemed unnecessary to ensure drug benefits outweigh risks.
The FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for type 2 diabetes medications containing rosiglitazone.
The agency reached this decision after monitoring the effects of rosiglitazone medications, which are approved as generics and brand names Avandia, Avandamet, Avandaryl. It ultimately deemed the REMS unnecessary to ensure that the drugs’ benefits outweigh their risks.
In 2013, the FDA determined that there was no increased risk of heart attack in patients treated with rosiglitazone compared with those treated with metformin and sulfonylurea. Subsequently, the FDA asked manufactures to remove prescribing and dispensing restrictions for medications containing rosiglitazone.
The agency did, however, require drug manufacturers to provide educational training to health care professionals to keep them informed on the latest findings regarding the potential link between rosiglitazone and heart disease risk.
In addition to contacting their health care professionals, patients who have experienced adverse reactions after taking these products should report them to the FDA’s MedWatch Adverse Event Reporting program.