The Food and Drug Administration (FDA) announced the removal of the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing medicines for type 2 diabetes. The REMS is no longer required to ensure that the benefits of rosiglitazone-containing medicines outweigh their risks.
The affected drugs include Avandia (rosiglitazone), Avandamet (rosiglitazone, metformin HCl), Avandaryl (rosiglitazone, glimepiride), and generics.
In 2010, the FDA had put in place certain prescribing and dispensing restrictions for rosiglitazone-containing medicines. A Rosiglitazone REMS program was required after analysis of short-term, randomized clinical trials suggested an elevated risk of heart attack with rosiglitazone use.
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But in 2013, the FDA removed these restrictions for rosiglitazone-containing medicines after clinical data showed no increased risk of heart attack compared to metformin and sulfonylurea. This decision was supported by a comprehensive re-evaluation conducted by the Duke Clinical Research Institute. As a result, the Rosiglitazone REMS program was also modified after re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial. While healthcare professionals, pharmacies, and patients were no longer required to enroll in the rosiglitazone REMS program, drug manufacturers were still required to provide educational training to healthcare professionals on the current state of knowledge concerning the cardiovascular risk of rosiglitazone medicines.
Through continued monitoring, the FDA has not identified any new pertinent safety information and has now determined that the REMS is no longer necessary.
The Agency will update the public as new information becomes available. Healthcare professionals are encouraged to report adverse events or side effects related to use of these products.
For more information visit FDA.gov.