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 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 off the market 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 are eligible to receive the drug and have been briefed on its risks. FDA expects the restricted plan “will limit use of Avandia significantly.”
“Although the European Medicines Agency went further by actually suspended marketing of the drug, both regulatory decisions result in essentially the same outcome, virtually complete elimination of the use of this drug by patients around the world,” said Dr. Steve Nissen of the Cleveland Clinic. Dr. Nissen, who published the first paper linking Avandia to heart risks, said only a small number of U.S. patients would receive the drug under the new restrictions.
The safety of Avandia, the brand name for rosiglitazone, has been the top drug safety controversy facing the FDA, and its split from European regulators is sure to draw criticism from public safety advocates and confuse patients.
The FDA’s top drug reviewer said the evidence against Avandia was not strong enough to warrant withdrawal.
“As a matter of prudence we are restricting access,” said the FDA’s Dr. Janet Woodcock. “We are not withdrawing the drug at this time because there is considerable uncertainty about this signal and whether or not it is valid.”
The decision marks the second time in three years that the agency has decided to leave Avandia on the market, despite mounting pressure from outside medical experts, politicians and some of its own scientists.
The FDA first approved the drug in 1999, and it became the top-selling diabetes pill in the world. Use has plummeted, however, since a 2007 analysis linked the drug to heart attack risks.
The European Commission still must approve the recommendations by the European Medicines Agency, a process that could take several weeks. Decisions by the health regulators usually are not challenged.
“In light of all the information available and including results from some very recent studies, the committee concluded that as of today, the benefits of rosiglitazone can no longer be considered to outweigh its risks,” Dr. Hans-Georg Eichler, EMA’s senior medical officer, said Thursday.
“Rosiglitazone was authorized more than 10 years ago,” he said. “Even at that time, there was a question mark over rosiglitazone’s cardiovascular safety.
“What you’re hearing today is the latest step in a chain of regulatory assessments and actions,” Dr. Eichler said.View Entire Story
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