FDA Lifts Final Regulatory Restrictions on Rosiglitazone

Miriam E Tucker

December 16, 2015

The US Food and Drug Administration (FDA) has removed the final remaining restrictions placed on the use of rosiglitazone.

In 2013, the FDA lifted restrictions the prescribing and use of the diabetes drug rosiglitazone (Avandia, Avandamet, Avandaryl, GlaxoSmithKline) on the basis of data, including from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, that demonstrated no elevated cardiovascular risk.

Now, the agency is lifting entirely the risk evaluation and mitigation strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which had included a requirement for the drug manufacturers to provide educational training to healthcare professionals about the current state of knowledge regarding the heart risks of rosiglitazone medicines. The manufacturers have now fulfilled these requirements.

The REMS was initially imposed in 2010. It included a requirement for special certification for healthcare providers who prescribe rosiglitazone. Only specially certified pharmacies could dispense it, and only patients who were already taking it before the restrictions or new patients who could not use any other glucose-lowering medications were eligible to take it.

Those moves came after publication of a meta-analysis in 2007 that raised concern about a possible increased cardiovascular risk. However, the RECORD trial and its subsequent readjudication were reviewed by two FDA advisory panels in June 2013. Of the 26 members of the combined panel, 13 members voted to keep rosiglitazone on the market and ease up on the restrictions.

"We have continued monitoring these medicines and identified no new pertinent safety information. 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," the FDA said in a statement.

Asked to comment, the author of that 2007 study, Cleveland Clinic cardiology department chair Steven E Nissen, MD, told Medscape Medical News, "The FDA notes that it removed the REMS in 2013. This is a nonevent....The drug is no longer used except in rare patients. It has been removed from the market by most other countries."


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.