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Medical News & Perspectives
December 25, 2013

FDA Eases Restrictions on the Glucose-Lowering Drug Rosiglitazone

JAMA. 2013;310(24):2604. doi:10.1001/jama.2013.284788

Dismissing concerns previously raised about increased risk of myocardial infarction and cardiac death associated with the diabetes drug rosiglitazone (Avandia), the US Food and Drug Administration (FDA) announced November 25 that it was lifting most restrictions on prescribing and use of the blood glucose–lowering drug.

Rosiglitazone gained FDA approval in 1999 and quickly became a multibillion blockbuster product for its manufacturer, GlaxoSmithKline (then SmithKline Beecham). But cardiovascular safety concerns were soon raised, ultimately leading to a 2007 meta-analysis suggesting that the drug increased myocardial infarction risk by more than 40% compared with placebo or a comparator drug.