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Allison Snoddy
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Avandia….It Could Be Back…

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On Monday a panel of independent experts suggested that drug regulators keep Avandia on the market even though Avandia is linked to increased heart problems. A study in the May 21 issue of the New England Journal of Medicine showed Avandia users — more than seven million around the world — had 43 percent greater risk of heart attack.

The Food and Drug Administration Advisory Committee agreed that current clinical trials showed Avandia increased the risk of heart attack in people suffering from type 2 diabetes. “Data does suggest there is an increased risk,” said committee president Clifford Rosen. Despite knowing Avandias risks, the experts voted 22-1 that the therapeutic benefits of Avandia outweighed its risks and tried to justify keeping it on the market. The panel’s decision is non-binding, although the FDA usually follows its recommendations. Several committee members suggested the FDA at least demand stronger warning labels on Avandia packages, but a doctor on the panel said the proposal was dropped because it lacked consensus. After the FDA panel’s recommendation to keep Avandia on the market, shares of GSK gained six percent closing at 52.45 dollars at the close of the New York Stock Market.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.