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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

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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."

But the FDA defended its decision to review the Duke re-analysis of the original trial.

"Given the public interest in Avandia, the extensive history of the product and the continued uncertainty of risk, the FDA is holding the advisory committee meeting to have a transparent, public discussion of the results of the RECORD readjudication," FDA spokesperson Morgan Liscinsky said.

Avandia quickly became a blockbuster diabetes drug following its release in 1999, with sales topping $3 billion in 2006.

But in 2007, Nissen published a study showing that Avandia raised the risk of heart attack by more than 40 percent. The outcry that followed led to Senate hearings in which the FDA's drug approval process came under intense scrutiny.

An FDA analysis of more than 50 studies of Avandia found that the drug was linked to an increased risk of heart problems. One study tied Avandia use to more than 47,000 cases of heart attack, stroke or heart failure during a 10-year period, even though the company-funded RECORD trial had not found an increased risk of cardiovascular trouble.

The FDA ended up pulling Avandia from pharmacy shelves in November of 2011, placing severe restrictions on the drug that limited its use to extremely ill diabetics. Patients wanting to take the medication now must enroll in a special program to qualify for its use.

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