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## FDA Panel Votes to Change Restrictions on Avandia

Controversial decision comes after a second look at major data review focused on heart risks
WebMD News from HealthDay

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By Dennis Thompson

HealthDay Reporter

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Blood Sugar Control and Insulin

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THURSDAY, June 6 (HealthDay News) -- An expert advisory panel to the U.S. Food and Drug Administration voted narrowly Thursday to recommend changing tough safety restrictions on the diabetes drug Avandia, which was all but banned nearly two years ago because of reported links to heart problems.

The panel's decision came after a review of data that suggested the medication might not be as harmful as once thought.

However, because of initial concerns over cardiovascular safety, Avandia had been taken off drugstore shelves and its use restricted to patients who first signed a waiver saying they understood the possible risks. The drug was also dispensed only through specially registered pharmacies.

But the new recommendation might change all that. Thirteen members of the 26-person panel voted to alter the safety restrictions, the Associated Press reported, while seven voted to remove the restrictions altogether. Five panelists voted to keep the restrictions in place, while one panelist voted to withdraw Avandia from the marketplace.

The exact nature of any changes to current restrictions are yet to be decided. The FDA is not obligated to follow its advisory panels' decisions, but it usually does.

The panelists spent the past two days reconsidering evidence from an independent review by Duke University researchers of Avandia's original clinical trial, called RECORD. That review did uncover some previously unreported cases of heart complications and deaths, but the Duke team concluded that those cases did not significantly raise the overall risk of heart disease.

"I'm considerably reassured, in light of the reanalysis, that the magnitude of risk we're talking about here is not very great," Dr. Dale Hammerschmidt, of the University of Minnesota, who voted on Thursday to modify the safety limits, told the AP.

The drug's maker, GlaxoSmithKline, which had funded the Duke review, said it was satisfied with the panel's decision.

"We appreciate the committee's thorough examination of the RECORD results and will continue to work with the FDA as it considers the recommendation of the committee," the company's chief medical officer, Dr. James Shannon, said in a statement. "We continue to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labeling."

Not everyone is likely to be so pleased. The FDA's reconsideration of Avandia's safety has prompted stinging criticism from the drug's detractors, who say the agency is trying to save face following a very public embarrassment over the drug.

"This is a drug that has essentially been off the market in almost the entire world for the last three years. It has been banned in most countries, and is available in the United States under such strict requirements that only 3,000 patients now take it," said Dr. Steven Nissen, the Cleveland Clinic cardiologist who first led the charge against Avandia. "It's really about the FDA wanting to clean up its image, not about whether the drug is actually safe or unsafe."

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