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Another Blow for Avandia

The Department of Veterans Affairs has decided to severely limit the use of Avandia, the once-popular drug for Type 2 diabetes, delivering another blow to the product’s maker, GlaxoSmithKline. The decision by the V.A. is likely to further reduce sales of Avandia, once a $2.2 billion franchise in this country alone. Sales of the drug in the United States have declined by an estimated 60 percent since May, when the New England Journal of Medicine published an analysis questioning the drug’s safety.

The V.A. makes up about 8 percent of Avandia’s sales, according to a Glaxo spokeswoman.
The May journal article suggested that using Avandia increased the risk of heart attack by more than 40 percent. The analysis, written by Dr. Steven E. Nissen and his colleagues at the Cleveland Clinic, prompted a review of Avandia by the FDA, that is still under way.

As part of that review, an agency advisory panel overwhelming recommended in July that the drug remain on the market. But such recommendations are not binding, and the agency is deeply split, with some officials pushing for Avandia’s withdrawal. One safety officer at the agency, Dr. David Graham, argued to the advisory panel that Avandia had caused up to 205,000 heart attacks and strokes since its approval in 1999.

The V.A. decided to remove Avandia, known generically as rosiglitazone, from its formulary on Oct. 5,. “The Department of Veterans Affairs conducted its own review and has concluded that, for some patients, rosiglitazone may not afford the same margin of safety as alternative drug therapies,” the statement said.

The agency, which treated more than five million veterans last year, issued 1,389,497 Avandia prescriptions to more than 161,000 individuals from September 2006 to August 2007.

The V.A. said Avandia would be available for patients already using it, if they decided to continue, but the agency is urging doctors to inform patients about the drug’s risks and benefits. “The V.A. will not provide it to patients for whom it is not currently prescribed,” the agency said.

Glaxo has said there were shortcoming in the methodology of Dr. Nissen’s study, a so-called meta-analysis of various clinical trials conducted by other researchers. The company argues that Avandia’s effect on the risk of heart attacks is similar to that of other oral medications for diabetes, including the older, widely used drugs metformin and sulfonylurea.

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DID YOU KNOW:
Pfizer discontinues the selling of Exubera:  After spending 2.8 billion dollars on marketing and research and only taking in 6 million dollars for 2007, they decided to stop manufacturing and selling the first inhaled insulin.  See this week’s Item  # 1

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