FDA removes restrictions on rosiglitazone

The FDA lifted prescribing and dispensing restrictions on the drug rosiglitazone, saying it did not pose increased cardiac risks compared with other diabetes medications.

“FDA is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010,” it wrote. “This decision is based on FDA review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute.”

In June, seven members of a panel convened by the FDA to review the safety of rosiglitazone recommended easing the restrictions, five recommended no changes and one suggested withdrawing it from the market. Rosiglitazone had been limited to use as a last resort option for patients who don’t respond to other medications.

“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, FDA's concern is substantially reduced,” the agency explained.

It recommended that patients with type 2 diabetes consult with their physicians to determine appropriate treatment options. Physicians no longer will be required to enroll in the Rosiglitazone Risk Evaluation and Mitigation Strategy program to prescribe or dispense the drug.