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April 10, 1981

Cimetidine Postmarket Outpatient Surveillance Program-Reply

Author Affiliations

Smith Kline & French Laboratories Philadelphia

JAMA. 1981;245(14):1409. doi:10.1001/jama.1981.03310390017004

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In Reply.—  We thank Mr Crawley and Drs Gardner and Lee for their comments on our article and appreciate the opportunity to respond.We believe an unfortunate and ambiguous choice of working on our part is responsible for their concern over the statement "deaths that occurred after stopping treatment were clearly unrelated to cimetidine." We did not mean to imply that because a death occurred after treatment with cimetidine (Tagamet), the drug could be exonerated from a relationship. As pointed out by Crawley and associates this would have negated an important aspect of the program. Actually, all deaths were carefully reviewed independently by two physicians, and it was only after this assessment that we were able to make the aforementioned statement. We apologize for the ambiguity.We tabulated patients rather than events in figuring the incidence of adverse reactions, because there was usually a striking overlap between two events when