The Food and Drug Administration on Thursday decided to restrict the use of the diabetes drug Avandia to patients with Type 2 diabetes who cannot control their diabetes on other medications. The decision comes in response to studies linking the GlaxoSmithKline drug to elevated risks of cardiovascular events such as heart attacks and strokes.
Senate Finance Committee Chair Max Baucus (D-Mont.), who along with ranking member Charles Grassley (R-Iowa) led a two-year inquiry into the drug, applauded the decision.
"Patients and doctors have a right to know the risks of the medicines they use and prescribe," Baucus said in a statement. "Our investigation into Avandia exposed major safety risks and showed that information is the most important tool the FDA has to protect American consumers. The FDA’s tough new restrictions on the drug will help protect patients. We will continue watching closely and working with the FDA to make sure patients and doctors are aware of the risks associated with Avandia and all drugs so they can make safe and informed decisions when choosing their medicines."
The consumer group Public Citizen wasn't satisfied.
"By failing to ban the dangerous diabetes drug, Avandia, generic name rosiglitazone, the Food and Drug Administration (FDA) again caved to industry pressure," Health Research Group Director Sidney Wolfe said in a statement. "Although the FDA has made progress highlighting the risks of using Avandia by severely restricting the drug, it did not go far enough. Too many people could still be exposed to this dangerous product. Rather, the FDA should have acted with its European counterpart and outright banned Avandia from the market."
The European Medicines Agency - the European Union's FDA equivalent - decided to suspend the drug on Thursday.
“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,” Ellen Strahlman, GSK’s Chief Medical Officer, said in a statement.