The diabetes drug Avandia will be pulled from retail pharmacy shelves in November because it poses such a big heart attack risk, the federal government announced Tuesday.
When the new program goes into effect on Nov. 18, only certified doctors will be allowed to prescribe the drug, and only to patients who've been informed of the risks and who will fill their prescriptions by mail order through specific pharmacies.
"It's like a decade-long nightmare coming to an end," said Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic. "Eleven years after this drug was introduced, it will be so restricted in access that virtually no one will be able to get it."
Avandia is the trade name for the drug rosiglitazone, which is also sold as a component in the combination drugs Avandamet and Avandaryl. From January through October of last year, almost half a million patients in the USA filled prescriptions for these products. By December, about 90,000 people were taking an Avandia-based medicine, says Bernadette King, of GlaxoSmithKline, the drug's maker.
In 2007, Nissen published an analysis showing that the drug increased heart attack risk by about 40% in people with type 2 diabetes, who are already much more prone to heart attacks than people without the disease. Subsequent studies confirmed the greater heart attack risk.
Under the new program, the FDA will limit the drug's use to patients who have already been safely treated with it, those whose blood sugar can't be controlled with other medications and who, informed of the risk, prefer this to other drugs. Avandia and Actos, an alternative to Avandia, were approved in 1999 to lower blood-sugar levels in patients with type 2 diabetes, which affects about 23 million Americans.
"I think it's a reasonable approach," said David Holmes, of the Mayo Clinic, president of the American College of Cardiology.
Other doctors have criticized the Food and Drug Administration for taking so long to impose new restrictions. In June 2010, more than half of the members of an FDA advisory committee recommended pulling Avandia from the market or tightening restrictions on its use. In September, the agency decided restrictions would be imposed.
Today, those restrictions were announced, to start in November.
"The decision was made last year that this was needed. Now they're finally announcing that we're finally going to have restrictions six months from now. It has taken more than a year to ensure that patients are truly informed of the risk," said Harlan Krumholz, a Yale cardiologist and longtime critic of the drug.
In 2007, FDA drug-safety expert David Graham reported to an advisory committee that Avandia had caused heart problems, including deaths, in 66,000 to 200,000 people.
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