FDA Lifts Rosiglitazone Prescribing Restrictions

Miriam E. Tucker

November 25, 2013

The US Food and Drug Administration (FDA) is lifting restrictions on the prescribing and use of the diabetes drug rosiglitazone (Avandia, Avandamet, Avandaryl, GlaxoSmithKline) on the basis of recent data that demonstrate no elevated cardiovascular risk.

"Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines still remains, in light of the new re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, our concern is substantially reduced," the FDA said in a statement.

Starting in 2010, the FDA began requiring 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 were taken 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 2 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.

Once the changes are final, the FDA anticipates that rosiglitazone's indication will be similar to those of other diabetes drugs; that is, "used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus."

The requirement for prescribers, pharmacies, and patients to enroll in the special program is expected to be lifted, and patients will be able to receive rosiglitazone through regular retail pharmacies and mail-order pharmacies. Manufacturers of rosiglitazone-containing drugs will be required to educate likely prescribers about the current state of knowledge on the cardiovascular risks of the medicines.

The FDA is also releasing GlaxoSmithKline from the postmarket requirement to conduct a clinical trial comparing rosiglitazone to pioglitazone, the only other approved drug in the thiazolidinedione class, and to standard diabetes drugs. "The FDA has concluded that this trial is no longer necessary or feasible," according to the statement.

GlaxoSmithKline issued a statement saying the company "welcomes the decision of the FDA and appreciates the agency's robust review of the science with regard to Avandia. [GlaxoSmithKline] maintains its view that Avandia is a safe and effective treatment for type 2 diabetes when used appropriately. The company will work with FDA to update labeling and to implement the agency's decision regarding easing restrictions on the medicine."

Rosiglitazone was pulled from the European market in 2010 at the same time the United States imposed restrictions. It remains unavailable there.


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