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Jamie Sheller
Jamie Sheller
Attorney • (800) 883-2299

New Safety Warnings Ordered for Avandia

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Following an analysis iindicating increased cardiovascular risks with use of Avandia, the FDA is ordering a new safety label for the drug. Advandia is used to treat diabetes. In May 2007 The New England Journal of Medicine published a meta-analysis showiing that use of Avandia was tied to an increased risk of myocardial infarction. Shortly after that publication, the FDA sought the label change to indicate the increased risk. There has also been a congressional hearing on how the FDA has handled Avandia since its 1999 approval. On June 30, the FDA will convene a safety panel to to review Avandia’s cardiovascular risks.