Famotidine: postmarketing clinical experience.

Abstract

A postmarketing survey of famotidine usage (phase IV survey) tracked 6346 patients at 602 locations from August 1985 to April 1986. Through the survey, the efficacy and the safety of famotidine were studied. The patients included 4618 cases of peptic ulcer, 106 cases of reflux esophagitis, 1006 cases of upper gastrointestinal tract bleeding, 343 cases of bleeding and ulcer prophylaxis, and 273 cases of gastritis and other diseases, totalling 6346 patients. Efficacy was analyzed by type of disease in terms of overall improvement; results of intermittent hemostatic efficacy were obtained for upper gastrointestinal tract bleeding; and safety was assessed. Overall, the results were good; the 8-week healing rate was 92.4%, and 72.3% of patients had their bleeding controlled within 7 days of beginning famotidine therapy. Side effects occurred in only 0.43% of patients, and abnormalities in laboratory test results were observed in less than 1% of patients. Gastrointestinal side effects, especially constipation, occurred most frequently. Most side effects were mild. The results of this postmarketing survey indicate that famotidine is a safe and effective H2-receptor antagonist.