April 10, 1981

Cimetidine Postmarket Outpatient Surveillance Program

Author Affiliations

Medication Monitoring Program Portage, Mich

JAMA. 1981;245(14):1409. doi:10.1001/jama.1981.03310390017003

To the Editor.—  Regarding the article by Gifford et al (1980;243:1532) on the postmarket surveillance (PMS) of cimetidine, if the goals of postmarket surveillance as outlined in the article can be realized, PMS programs can be of value to individual clinicians, the pharmaceutical industry, and federal agencies.Some questions arose that we think were not completely addressed in the article. These pertain to the method employed by Gifford and his group in the reporting of adverse effects. Perhaps the most important was the method of assigning causality in assessing the reports of deaths. We refer specifically to the statement that "deaths that occurred after stopping treatment were clearly unrelated to cimetidine." In assessing the possible drug relatedness of these deaths, one must consider whether the onset of the precipitating event leading to death was within the prescribing time frame. To consider only the end point of death could lead to