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Researchers, led by an FDA official, have assessed in more detail the cardiac risk associated with use of the now-withdrawn COX-2 inhibitor Vioxx (rofecoxib). They analyzed data from 1.4 million patients enrolled in a California HMO who had filled at least one nonsteroidal anti-inflammatory drug (NSAID) prescription from 1999 through 2001, including for COX-2 selective NSAIDs (rofecoxib and celecoxib) and nonselective NSAIDs.
During 2.3 million person-years of follow-up, there were 8143 cases of acute MI or sudden cardiac death, each matched with four controls who had not suffered these events. Current NSAID use was defined as overlap between the prescription period and the index date, and remote use as a prescription that ended more than 60…