FDA removes REMS labeling from rosiglitazone-containing type 2 diabetes medications

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The FDA announced on Dec. 16 that it would eliminate the Risk Evaluation and Mitigation Strategy (REMS) labeling on type 2 diabetes medications that contain rosiglitazone.

Branded medications that contain rosiglitazone include Avandia (rosiglitazone), Avandamet (rosiglitazone plus metformin) and Avandaryl (rosiglitazone plus glimepiride). There are also generic versions of rosiglitazone.

Patients with type 2 diabetes can control blood sugar by taking rosiglitazone in combination with diet and exercise.

After evaluating a meta-analysis that found an elevated risk of cardiovascular events in patients taking rosiglitazone, the FDA in 2010 restricted use of rosiglitazone only to patients who could not control their type 2 diabetes with other medications.

Three years later, the FDA removed prescribing and dispensing restrictions for rosiglitazone-containing products. At the time, the agency analyzed results of the RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes) trial, which found patients who received rosiglitazone had no increased risk of MI or death compared with those who received metformin and sulfonylurea.

“We have continued monitoring these medicines and identified no new pertinent safety information,” the agency said in a drug safety communication. “As a result, we have determined the REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks. We will update the public if any new information becomes available.”