FDA to Lift Restrictions on Avandia for Diabetes
FDA to Lift Restrictions on Diabetes Drug Avandia
The U.S. Food and Drug Administration announced Monday that it is lifting the tough safety restrictions it imposed on the diabetes drug Avandia two years ago because of reported links to heart 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.
Avandia 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 Avandia. But an independent review by Duke University researchers, based on Avandia's original clinical trial, concluded that patients had no elevated risk of heart attack or death compared with those taking standard diabetes drugs.
"Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug," Janet Woodcock, M.D., 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."