In July, it looked like the Food and Drug Administration was going to be Avandia’s saving grace, when a 33-person panel voted to allow the diabetes medication to stay on the market. Many felt the decision would stave off litigation against its manufacturer, GlaxoSmithKline. But today, the agency announced a heavy restriction Avandia, although they will not be pulling the drug off the U.S. market. The European Medicines Agency, FDA’s counterpart in the EU, has decided to ban the drug.
Avandia has been associated with an increased risk of heart problems, including heart attacks and strokes. The new FDA regulations will now restrict the use of Avandia to only those suffering from type 2 diabetes who cannot achieve glycemic control on other medications. The FDA is further requiring GlaxoSmithKline to pay for a new independent study that will compare Avandia with Actos, the competing diabetes drug. They are also asking the manufacturer to tightly regulate the future distribution of Avandia.
GlaxoSmithKline continues to stand behind its product. In a statement, they wrote that “The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions.”
September 23rd, 2010