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?
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The Rational Clinical Examination
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