European regulators ordered the diabetes drug Avandia off the market and the Food and Drug Administration placed stringent restrictions on its use in the United States, saying heart attack risks associated with the former blockbuster are too great a safety concern to continue its use for most people.
In simultaneous news briefings Thursday, the European Medicines Agency and the U.S. Food and Drug Administration announced their long-awaited decisions on the fate of GlaxoSmithKline’s controversial drug. The European regulator said it would stop authorizing marketing of Avandia, which will be banned from sales within the next few months.
The FDA said new patients will be able to get a prescription for Avandia, but only if they can’t control their blood sugar with other medications. Doctors will have to document that their patients have been briefed on its risks. FDA expects the restricted plan “will limit use of Avandia significantly.”
The two decisions will virtually eliminate use of the drug around the world, said Dr. Steve Nissen of the Cleveland Clinic.
“To prescribe this drug in the U.S., you now have to certify that the patient has tried every other diabetes drug, and there are no patients who only respond to Avandia,” said Nissen, who published the first paper linking Avandia to heart risks.
In the U.S., more than 2.6 million patients filled prescriptions for Avandia last year. Anyone already taking Avandia will need to sign a waiver saying that they understand the drug’s risks.
The safety of Avandia, the brand name for rosiglitazone, has been the top drug safety controversy facing the FDA in recent years. FDA’s critics have framed the Avandia decision as a key test of the agency’s Obama-appointed leadership, who vowed to bolster the agency’s regulatory stance after a series of drug safety problems under the previous administration.
“We are taking somewhat different strategies, but both strategies are designed to assure the goals of safety,” FDA Commissioner Margaret Hamburg said.