US FDA eliminates the REMS on rosiglitazone diabetes drugs

The US Food and Drug Administration is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines.

Rosiglitazone-containing drugs are approved as UK pharma major GlaxoSmithKline’s (LSE: GSK) Avandia, Avandamet and Avandaryl, and generics. The FDA said that the REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.

In 2013, FDA required removal of the prescribing and dispensing restrictions for rosiglitazone medicines after determining that data did not demonstrate an increased risk of heart attack with rosiglitazone medicines compared to the standard type 2 diabetes medicines metformin and sulfonylurea. 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. Manufacturers have since fulfilled these requirements.