GlaxoSmithKline's controversial diabetes drug Avandia will remain on the U.S. market, but its use will be tightly restricted, the Food and Drug Administration announced Thursday.
The FDA's European Union counterpart, the European Medicines Agency, said it was suspending Avandia sales but not revoking its license, leaving the door open for its return.
Steven Nissen, cardiovascular medicine chair at the Cleveland Clinic, first raised concerns about Avandia's safety in a May 2007 medical journal study. He concluded that Avandia might raise the risk of a heart attack or blocked artery.
In July, a 33-member advisory panel split on what the FDA should do: 12 said it should pull Avandia; 10 said the FDA should restrict sales.
Still, FDA Commissioner Margaret Hamburg said at Thursday's news conference, "we heard very clearly both from providers and patients" that in some cases Avandia was the only diabetes drug that controlled blood sugar or could be tolerated.
The FDA also decided that only patients who can't control their blood sugar with other types of drugs and cannot take Actos, the other drug in the same class, will be able to start on Avandia. Patients already taking it will be allowed to continue. Doctors will have to attest to and document that patients are eligible to take Avandia.
Joshua Sharfstein, FDA's principal deputy administrator, said the restricted access and new label information about it will be in place in "several months."
Sales of Avandia, which quickly became a blockbuster after approval in 1999, plummeted after Nissen's meta-analysis. Prescriptions filled in the USA fell from 5.6 million in June 2007 to just 1 million this past May, according to IMS Health, which tracks drug sales.
About 600,000 people currently take Avandia or one of two combination products that contain it, Hamburg said, adding, "I think that the numbers will go down very significantly, given these requirements."
In a statement, GlaxoSmithKline said it "continues to believe that Avandia is an important treatment for patients with type 2 diabetes."
Nissen said Thursday he would have preferred withdrawal of Avandia. Still, suspension of sales in Europe and restricted access in the USA will spur more doctors to stop prescribing it, he said. "Essentially, the drug is gone." But he called it "a tragedy" that it took so long to restrict its use.
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