HealthDay News — The FDA has announced that it is lifting the tough safety restrictions it imposed on the diabetes drug rosiglitazone (Avandia) two years ago because of reported links to cardiovascular problems.
The agency’s decision was expected, and follows up on a June vote by an expert advisory panel to rescind the restrictions, based on new data that suggested the medication may not be as harmful as once thought.
Rosiglitazone had been taken off drug store shelves in 2011, and its use restricted to patients who first signed a waiver saying they understood the possible risks. Only specially registered pharmacies could dispense the drug.
But an independent review by Duke University researchers of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) clinical trial concluded that patients taking rosiglitazone had no elevated risk of myocardial infarction or death compared with those taking standard diabetes drugs, and do not confirm the signal of increased risk of myocardial infarction that was found in a meta-analysis of clinical trials first reported in 2007.
“Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Given these new results, our level of concern is considerably reduced. Thus, we are requiring the removal of certain prescribing restrictions.”
The FDA decision will require modifications to rosiglitazone’s labeling about cardiovascular safety, require changes to the Risk Evaluation and Mitigation Strategy (REMS) program and will drop a postmarket study requirement imposed on the drug’s manufacturer, GlaxoSmithKline.
Once the changes are final healthcare providers, pharmacists and patients will no longer be required to complete REMS, and rosiglitazone will be available in regular retail and mail-order pharmacies.
The medication’s indication will likely be similar to other currently available diabetes medications, with a recommendation for use along with diet and exercise to improve blood glucose control in patients with type 2 diabetes.
Steven Nissen, MD, head of cardiology at Cleveland Clinic, whose 2007 metaanalysis of 42 studies showed rosiglitazone increased the risk for myocardial infarction 43%, has criticized the FDA decision.
“This decision is not in the public interest,” Nissen said. “It’s really more about the FDA than it is about the drug. It does not make any good regulatory sense, and in fact it’s rather bizarre.”
Despite the redacted restrictions, widespread use of the drug is unlikely in the future, Nissen said, because too many concerns have been raised about the drug’s safety.