V.A. Limits Glaxo Drug Widely Used For Diabetes
[2008-4-9]
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 Food and Drug Administration 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 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 Food and Drug Administration 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 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 Food and Drug Administration 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 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 Food and Drug Administration 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.
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