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Avandia boxed warning on label updated by USFDA PDF Print E-mail
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Written by Administrator   
Thursday, 15 November 2007

USFDA ask the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks

The U.S. Food and Drug Administration has asked the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.

People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

Avandia, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa., was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels. Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

 
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