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Consumer Group Seeks FDA Ban on Avandia
Date:10/30/2008

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The group said safer, more effective drugs for type 2 diabetes included metformin (brand name Glucophage) and glipizide (brand name Glucotrol). Pioglitazone (brand name Actos) isn't recommended, because it shares most of Avandia's toxicities, with the exception of heart attack risk.

Avandia is sold by GlaxoSmithKline. In a statement, the company said that it had not yet looked at the petition but said that "we do not believe there is a connection between liver toxicity and this medicine," the Wall Street Journal reported Thursday. Avandia was safe and effective when used appropriately, the company added.

An estimated 20.4 million Americans have type 2 diabetes, which can lead to kidney failure, blindness and heart disease. About 75 percent of diabetics die from cardiovascular disease.

In July, an FDA advisory panel said drugs designed to control type 2 diabetes should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems. They recommended that all makers of these drugs conduct long-term cardiovascular trials, even if the drugs show no signs of heart problems in initial trials.

Most of the outside experts on the panel also said that trials assessing cardiovascular risk should be done before a drug is approved, perhaps as part of a phase III trial, to rule out any significant heart risk. Long-term trials could follow once the drug was on the market.

Currently, the FDA only requires that drugs for type 2 diabetes lower blood sugar, which is believed to protect diabetics from the debilitating side effects of the disease.

More information

Consumers Union has more about diabetes drugs.



-- Robert Preidt



SOURCE: Public Citizen, news r
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