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Health Agencies Update
December 26, 2007

FDA Rosiglitazone Warning

JAMA. 2007;298(24):2858. doi:10.1001/jama.298.24.2858-a

A new boxed warning on rosiglitazone, a drug used to treat type 2 diabetes, warns physicians and patients about potential cardiovascular risks associated with the drug, the US Food and Drug Administration (FDA) announced in November.

The new warning notes that a meta-analysis of 42 studies (most comparing the drug with placebo) involving 14 237 patients suggested that rosiglitazone may increase the risk of myocardial ischemic events such as angina or myocardial infarction. However, it also states that 3 other studies comparing rosiglitazone with other diabetes medications or placebo were inconclusive.

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