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On September 30, 2004, Merck voluntarily withdrew its cyclooxygenase (COX)-2 inhibitor rofecoxib (Vioxx) from the market. The action followed analysis of interim data from the Adenomatous Polyp Prevention On Vioxx (APPROVe) study, which showed a significant increase in rates of myocardial infarction and stroke among patients who received rofecoxib for longer than 18 months, compared with patients who received placebo.
Rofecoxib was first marketed in 1999. The following year, a randomized trial in arthritis patients (VIGOR) revealed increased rates of adverse cardiovascular events among patients who took rofecoxib compared with patients who took naproxen (Journal Watch Dec 8 2000). Merck researchers attributed this difference to cardioprotect…