Cimetidine Postmarket Outpatient Surveillance Program: Interim Report on Phase I

Autor: Gifford, Lawrence M., Aeugle, Margaretta E., Myerson, Ralph M., Tannenbaum, Philip J.
Zdroj: JAMA: Journal of the American Medical Association; April 1980, Vol. 243 Issue: 15 p1532-1535, 4p
Abstrakt: A postmarket surveillance program in outpatients receiving cimetidine was initiated seven months after its approval for marketing. During the first phase of the program, data were obtained over a three-month period for 9,907 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 results confirmed the safety profile of cimetidine. A follow-up phase, initiated six months after the initial phase of the surveillance program, will provide longer-term data on these patients.(JAMA 243:1532-1535, 1980)
Databáze: Supplemental Index