Cimetidine postmarket outpatient surveillance program. Interim report on phase I

Abstract

A postmarket surveillance program in outpatients receiving cimetidine [histamine-2 blocker; CM] was initiated 7 mo. after its approval for marketing. During the first phase of the program, data were obtained over 3 mo. period for 9907 patients who received the drug. The overall incidence of adverse effects reported was 4.4%, and the types of adverse effects did not differ from those reported in premarketing controlled studies. Physician response was excellent (85.1%), and the methods used were successful in providing data on a large number of patients who received the drug in routine clinical practice. The safety profile of CM was confirmed. A follow-up phase, initiated 6 mo. after the initial phase of the surveillance program, will provide longer-term data on these patients.