Sept. 23, 2010 -- The U.S. Food and Drug Administration today announced it will significantly restrict the use of the diabetes drug rosiglitizone -- popularly known as Avandia -- after subsequent reviews of the drug suggest a higher risk of heart attack.
Meanwhile, the European Medicines Agency, the FDA's European counterpart announced it will stop marketing of the drug altogether.
"While each agency operated on its own in making this decision, they did not operate in isolation," said Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA. Woodcock said both agencies reviewed the same data and knew about the separate decisions.
The FDA will require stringent monitoring requirements for the drug's manufacturer, GlaxoSmithKline, under the agency's Risk Evaluation and Mitigation Strategies (REMS).
Under the new restrictions, patients currently taking Avandia will be able to continue taking the drug, but will have to sign a consent stating that they understand the potential risks involved.
"Patients will only be allowed to use [Avandia] if they acknowledge and document the risk of this drug," said Dr. Joshua Sharfstein, FDA principal deputy commissioner.
Doctors may only consider prescribing Avandia to patients if they have exhausted all other medications, including the drugs market competitor, Actos.
In a written statement, Dr. Ellen Strahlman, GSK's Chief Medical Officer, said, "Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients."
After initial reports of potential heart risk, yearly Avandia sales in the U.S. dropped from 13.3 million prescriptions in 2006 to 2.6 million in 2009, according to the pharmaceutical firm IMS Health.
The drug lost more than half of its sales since a 2007 review of studies found that Avandia posed an increased risk for heart problems compared to its market competitor Actos.