Postmarketing surveillance of the safety of cimetidine: mortality during second, third, and fourth years of follow up.

doi:10.1136/bmj.291.6502.1084

Br Med J (Clin Res Ed) 1985;291:1084-1088 (19 October), doi:10.1136/bmj.291.6502.1084

Postmarketing surveillance of the safety of cimetidine: mortality during second, third, and fourth years of follow up.

D G Colin-Jones, M J Langman, D H Lawson, M P Vessey

A previous report analysed the pattern of mortality during thefirst year of follow up among 9928 patients taking cimetidinewho were recruited to a postmarketing drug surveillance studyin Glasgow, Nottingham, Oxford, and Portsmouth. A further analysishas now been conducted extending the period of follow up tofour years. The 12 month report noted that cimetidine was beinggiven, knowingly or unknowingly, in the late stages of manydiseases and also to counter the adverse gastric effects ofother drugs used in the treatment of serious disorders. Thisfinding was underlined by a steady fall in the excess deathrate among cimetidine users with increasing length of followup, such that by the fourth year the pattern of observed deathswas not much different from that expected on the basis of nationalrates. Some excess of observed over expected deaths from gastriccancer, lung cancer, and urinary disorders was still apparentafter four years of follow up, but there was no evidence thatcimetidine was responsible. Indeed, no fatal disorder emergedas being associated with cimetidine during the follow up period.Deaths from the complications of disease related to gastricacid occurred in only 38 of the 9928 subjects over the fouryears. These findings provide further evidence of the safetyof cimetidine.

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