Fierce Debate Within FDA Over Safety of Type II Diabetes Drug

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March 11, 2010  The Laura And Wagner Foundation Wellness Information Center

"If all diabetics now taking Avandia were given Takeda's Actos drug instead, about 500 heart attacks and 300 cases of heart failure would be averted each month because Avandia, also known as rosiglitazone, can be harmful to the heart" - "Rosiglitazone should be removed from the market," one report, by Dr. David Graham and Dr. Kate Gelperin of the FDA concluded, according to the New York Times, which said both authors recommended Avandia's withdrawal from the market.

Sales of Avandia plummeted about two years ago after another study in the U.S. linked it to an increased risk of a heart attack. In 2009,
a Canadian study found that Avandia was associated with an increased risk of heart failure and death among older patients compared with Actos.

Glaxo contested the findings, which it said did not reflect evidence from two randomized controlled trials comparing Avandia and Actos that found no differences in heart failure. The Times also reports that a bipartisan U.S. Senate investigation said Glaxo failed to warn patients earlier that Avandia was potentially deadly.

in December, 2009, the director of the FDA's drug center, Dr. Janet Woodcock, ordered that another advisory committee evaluate whether the drug should be sold or removed from the market. In the meantime, the agency is recommending that patients not stop taking the medication and check with their doctors.

Read the FDA's official statement here.


GLAXO STATEMENT: Drug maker defends its handling of Avandia heart risks