FDA LIFTS SOME RESTRICTIONS ON AVANDIA
c.2013 New York Times News Service
The Food and Drug Administration removed some restrictions on the prescribing and use of the diabetes drug Avandia on Monday, saying that new research showed the drug did not increase the chances of heart attacks.
Avandia has gone from being one of the industry’s biggest blockbusters to a marginalized drug used by just a few thousand people, after a 2007 analysis of the drug showed that taking it could greatly increase the risk of heart attack.
The agency said on Monday that the new figures “do not confirm” the finding of that analysis. The data comes from an outside review of an old clinical trial conducted by the drug’s maker, GlaxoSmithKline. In June, the agency convened a panel of experts to look at the review and that panel voted to loosen restrictions.
Some researchers had criticized the original trial as flawed and argued that re-evaluating an old trial amounted to relitigating a case that had already been closed. Others questioned its independence, as Glaxo paid for it.
But the agency and the drug company have argued that the data was the best the medical community had from which to draw conclusions about a potentially lifesaving drug in the midst of a diabetes epidemic. The agency said the data showed no elevated risk for Avandia, when compared with standard diabetes drugs.
“Given these new results, our level of concern is considerably reduced,” said Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research.
Doctors said the move by the agency was unlikely to breathe new life into the drug, which has been largely discredited in the U.S. and was withdrawn from the market in Europe in 2010. Glaxo paid $3 billion in fines because of practices involving several drugs, including a failure to report safety updates about Avandia.
“The decision by the FDA is irrelevant in clinical practice,” said Dr. Ronald Tamler, clinical director of the Mount Sinai Diabetes Center at Mount Sinai Hospital in Manhattan. He said that after years of warnings about the drug, patients would not “abandon their concerns overnight.”
Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, who sounded the initial public alarm, contended that the agency was trying to rewrite an embarrassing episode in its history, a charge the agency denied.
In a statement, Glaxo said that it “maintains its view that Avandia is a safe and effective treatment for Type 2 diabetes when used appropriately.”