FDA to Lift Restrictions on Diabetes Drug Avandia
MONDAY, Nov. 25, 2013 -- The U.S. Food and Drug Administration announced Monday that it is lifting the tough safety restrictions it imposed on the diabetes drug Avandia two years ago because of reported links to heart problems.
The agency's decision was expected, and follows up on a June vote by an expert advisory panel to rescind the restrictions, based on new data that suggested the medication may not be as harmful as once thought.
Avandia had been taken off drug store shelves in 2011, and its use restricted to patients who first signed a waiver saying they understood the possible risks. Only specially registered pharmacies could dispense Avandia.
But an independent review by Duke University researchers, based on Avandia's original clinical trial, concluded that patients had no elevated risk of heart attack or death compared with those taking standard diabetes drugs.
"Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "Given these new results, our level of concern is considerably reduced. Thus, we are requiring the removal of certain prescribing restrictions."
Dr. Steven Nissen, head of cardiology at Cleveland Clinic, first sounded the alarm about Avandia in 2007 with an analysis of 42 studies that showed that the medication caused a 43 percent increased risk of heart attack.
Following his study, an FDA analysis of more than 50 studies concluded that Avandia was linked to an increased risk of heart problems, and the agency decided to pull the drug from pharmacy shelves.
However, the FDA also asked drug maker GlaxoSmithKline to review key aspects of Avandia's clinical trial related to heart safety. This was the review that led to Monday's decision.
Nissen condemned the FDA's latest action.
"This decision is not in the public interest," Nissen said. "It's really more about the FDA than it is about the drug. It does not make any good regulatory sense, and in fact it's rather bizarre."
Dr. Bob Eckel, a past president of the American Heart Association, greeted the news with more of a shrug.
"I think they've made the appropriate decision based on the updated evidence," Eckel said. "It's consistent with the latest evidence."
Both Nissen and Eckel agreed that widespread use of Avandia is not likely to resume, regardless of the FDA's change of heart, because too many concerns have been raised regarding the drug's safety.
"The good news is physicians are not going to start using this drug again. It's basically an obsolete drug, so this will have no practical implications," Nissen said. "Who's going to use it? What patient is going to take it and what doctor is going to prescribe it, given everything we know?"
Another expert agreed. "The decision by the FDA is irrelevant in clinical practice," said Dr. Ronald Tamler, clinical director of the Mount Sinai Diabetes Center at The Mount Sinai Hospital in New York City. "Patients have been reading about increased risk of cardiovascular events with Avandia since 2007 and will not abandon their concerns overnight, despite the FDA decision. Moreover, a medication with similar properties, pioglitazone [Actos], is available as a generic drug at a much lower cost."
In its heyday, Avandia was a blockbuster diabetes drug for maker GlaxoSmithKline, with about $3.2 billion in sales posted in 2006.
Under the FDA's decision, the drug's information will be changed to reflect that Avandia may be used along with diet and exercise to improve control of blood sugar in type 2 diabetes patients. Patients will be able to receive the medication through regular and mail-order pharmacies.
For more on Avandia, go to the U.S. National Library of Medicine.
Posted: November 2013
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