Adverse event data from clinical trials must inform decision making

These are trying times for patients with chronic musculoskeletal pain. Worrying data about the drugs they regularly use keep emerging. In September 2004 rofecoxib (Vioxx) was withdrawn by Merck after the adenomatous polyp prevention on Vioxx (APPROVe)1 trial showed an increase in major cardiovascular events in patients with a history of colorectal adenomas who were randomised to receive Vioxx, compared with those in the placebo group.^w1Rofecoxib had been marketed as the non-steroidal anti-inflammatory drug (NSAID) of choice because selective inhibition of the isoform 2 of the cyclooxygenase (COX 2) enzyme made it highly effective but free from gastrointestinal toxicity.

More unwelcome data from placebo controlled trials of rofecoxib's competitors followed: valdecoxib (Bextra, Pfizer) taken after coronary artery bypass grafting was shown to be associated with an increased incidence of cardiovascular events2; and the adenoma prevention with celecoxib (APC) trial3 reported an increased risk of cardiovascular events associated with use of celecoxib (Celebrex, Pfizer), a drug known to be less selective …