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Bridget M. Kuehn

JAMA. 2007;298(24):2858.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Based on this information, the FDA has concluded that there is not sufficient evidence to determine whether rosiglitazone poses a greater heart risk than other diabetes medications, according to a statement. The agency also has requested that the drug's manufacturer, GlaxoSmithKline, headquartered in Brentford, United Kingdom, conduct a long-term follow-up study.

The updated warning was recommended by . . . [Full Text of this Article]