Eleven Deaths Among UK Vioxx Users
The new selective COX-2 inhibitors Vioxx and Celebrex have been touted as a new panacea for arthritic disorders. Although the incidence of ulcers does appear reduced, we still cannot view these drugs as completely safe.
(article) Eleven deaths and more than 1,000 reports of suspected adverse reactions to Merck’s new osteoarthritis drug Vioxx (rofecoxib) have been reported in the UK since its launch in June last year, British regulators said on Thursday. Five patients died following gastrointestinal reactions, three following cardiac failure and three following myocardial infarction, the agencies reported in their newsletter “Current Problems.” An estimated 557,100 prescriptions for Merck’s COX-2 inhibitor have been dispensed in the UK up to the end of May 2000, the agencies said. The rate of reported adverse reactions is therefore approximately one per 500 prescriptions. The newsletter reminded prescribers that rofecoxib is contraindicated in patients with active peptic ulceration, GI bleeding, and severe congestive heart failure. It also noted that “caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing oedema for any other reason”. In conclusion, the agencies said, “As with all new drugs, the safety of rofecoxib remains under close review.” They pointed out that another COX-2 inhibitor, Pharmacia’s celecoxib (Celebrex), had been launched recently and promised to report on its safety profile in a forthcoming bulletin. Merck officials were not immediately available for comment.