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Analysis: Panel says Avandia should stay.

UPI Health Business

| July 31, 2007 | COPYRIGHT 2007 United Press International. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Byline: TODD ZWILLICH

WASHINGTON, July 30 (UPI) -- GlaxoSmithKline's type 2 diabetes drug Avandia should remain on the market, despite concerns that it may promote heart attacks and other cardiovascular problems, a Food and Drug Administration advisory panel said Monday.

Experts overwhelmingly said they were convinced that the drug, also called rosiglitazone, can increase the risk of myocardial infarctions and other dangerous heart problems. But they then voted 22 to 1 to urge the FDA to allow continued sales to U.S. patients because the risk appeared to be confined to patients already at risk for heart disease.

The decision came despite calls from some FDA officials to pull Avandia from the U.S. market. The FDA does not have to follow its advisory committees' recommendations, but usually does.

Avandia is used by patients with type 2 diabetes to help control blood sugar. Unlike insulin, which controls short-term blood-sugar fluctuations, Avandia and drugs like it offer more long-term control. Millions of patients have taken Avandia, as well as a similar drug called Actos, or pioglitazone.

Monday's decision comes after three studies -- including one performed by GSK -- concluded that Avandia boosted the risk of heart attacks and other cardiovascular problems by 30 percent to 40 percent in patients with type 2 diabetes.

One FDA estimate suggested that the drug may have been responsible for added heart problems in 66,000 to 200,000 patients since it was first approved in 1999. David Graham, an FDA safety officer who performed that study, urged that the drug be taken off the market because it had shown few benefits over other similar drugs.

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