Worldwide safety experience with nabumetone.

Nabumetone has undergone human clinical premarketing and postmarketing testing for efficacy and safety for about 10 years. In the United States and elsewhere, 7,241 patients were evaluated in clinical trials and comparative information with placebo, aspirin, and other nonsteroidal antiinflammatory drugs (NSAID) was gathered. Postmarketing surveillance information was gathered for 37,712 patients in the United Kingdom and Germany. Withdrawal rates due to adverse effects ranged from 3 to 13%. The cumulative incidence of nabumetone-induced perforations, ulcers, or bleeds varied from 0.02 to 0.95%. In all patients evaluated, only 2 deaths and 15 hospitalizations could be attributed to nabumetone therapy. Bone marrow suppression, liver necrosis, serious central nervous system conditions, or life-threatening dermatologic reactions did not occur. No increase in toxicity was noted with increased dose (up to 2000 mg/day) or age. Nabumetone was determined to be a safe NSAID that causes a low incidence of ulcers.