Research Article

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

Br Med J (Clin Res Ed) 1985; 291 doi: https://doi.org/10.1136/bmj.291.6502.1084 (Published 19 October 1985) Cite this as: Br Med J (Clin Res Ed) 1985;291:1084
  1. D G Colin-Jones,
  2. M J Langman,
  3. D H Lawson,
  4. M P Vessey

    Abstract

    A previous report analysed the pattern of mortality during the first year of follow up among 9928 patients taking cimetidine who were recruited to a postmarketing drug surveillance study in Glasgow, Nottingham, Oxford, and Portsmouth. A further analysis has now been conducted extending the period of follow up to four years. The 12 month report noted that cimetidine was being given, knowingly or unknowingly, in the late stages of many diseases and also to counter the adverse gastric effects of other drugs used in the treatment of serious disorders. This finding was underlined by a steady fall in the excess death rate among cimetidine users with increasing length of follow up, such that by the fourth year the pattern of observed deaths was not much different from that expected on the basis of national rates. Some excess of observed over expected deaths from gastric cancer, lung cancer, and urinary disorders was still apparent after four years of follow up, but there was no evidence that cimetidine was responsible. Indeed, no fatal disorder emerged as being associated with cimetidine during the follow up period. Deaths from the complications of disease related to gastric acid occurred in only 38 of the 9928 subjects over the four years. These findings provide further evidence of the safety of cimetidine.