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FDA to Lift Restrictions on Diabetes Drug Avandia

Not all experts are happy with granting wider access to the troubled medication, however

WebMD News from HealthDay

By Dennis Thompson

HealthDay Reporter

MONDAY, Nov. 25, 2013 (HealthDay News) -- 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."

Not everyone agreed with him, however.

Dr. Yehuda Handelsman, an endocrinologist in Tarzana, Calif. and incoming president of the American College of Endocrinology, applauded the FDA for "doing what's right by standing up for the science."

"I thought it was about time. Many of us never thought the information brought against the drug was very scientifically solid or correct," Handelsman said of the announcement.

For his part, 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."

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