Author Affiliations: Division of Pharmacoepidemiology (Drs Solomon and Winkelmayer) and Rheumatology, Immunology, and Allergy (Dr Solomon), and Renal Division (Dr Winkelmayer), Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
In 2005, the US Food and Drug Administration (FDA) held an advisory committee meeting to help determine the safety of selective cyclooxygenase 2 (COX-2) inhibitors, a popular group of drugs with a novel mechanism of action but with incompletely understood effects on the cardiovascular system. Although these drugs have some potential benefits with respect to gastrointestinal toxic effects, their benefit-risk ratio was and is still unclear. Fast forward 2 years to 2007, and the FDA held a similar advisory committee meeting about the safety of rosiglitazone, a widely used thiazolidinedione (TZD) with known benefits on glycemic control but potential cardiovascular toxic effects. What have clinicians, patients, and the public learned through these recent events?
Solomon DH, Winkelmayer WC. Cardiovascular Risk and the Thiazolidinediones: Déjà Vu All Over Again? JAMA. 2007;298(10):1216–1218. doi:10.1001/jama.298.10.1216
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