Popular diabetes drug under fire

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by JANET ST. JAMES

WFAA

Posted on July 13, 2010 at 9:38 PM

A popular diabetes drug is under fire as an FDA advisory committee determines whether it's too dangerous to stay on the market.

A number of studies show Avandia increases potentially deadly heart problems. Doctors are waiting to see what the FDA panel decides, and they say patients should, too.

Avandia was once the world's best-selling diabetes pill. When it was approved by the FDA in 1999, there were few drugs on the market to treat Type 2 diabetes, the most common form of the disease. There are now more than 30 medications in the same category.

While Avandia does lower blood glucose levels, several studies show the drug also increases the risk of heart attack, stroke, and death.

An FDA advisory committee is examining all the evidence before making a recommendation that could require more warning labels — or pull the drug from the market altogether.

"The FDA may end up taking the drug off the market, yet allow ongoing research to continue," said UT Southwestern cardiologist Darren McGuire, who sits on an FDA panel.

Dr. McGuire specializes in treating heart patients with diabetes, and he does not prescribe Avandia. "I saw this signal years ago, and I believed it was real."

He says heart patients are at more serious risk, but any patient on Avandia should talk to their doctor about alternatives before quitting the medication.

The FDA advisory panel meets on Wednesday and is expected to make a recommendation to the agency after that.

While the FDA doesn't have to follow the committee's advice, they most often do.

E-mail jstjames@wfaa.com

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