BMJ 1994;308:503-506 (19 February)

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Risk of gynaecomastia associated with cimetidine, omeprazole, and other antiulcer drugs

L A Garcia Rodriguez, H Jick 

Boston Collaborative Drug Surveillance of Program, Boston University Medical Centre, Lexington, MA 02173-5207, USA.

Abstract

Objective : To study the risk of gynaecomastia associated with cimetidine, misoprostol, omeprazole and ranitidine.
Design : Open cohort study with nested case-control analysis.
Setting : General practices in United Kingdom that had computerised offices, 1989-92.
Subjects : 81 535 men aged 25-84 years who received at least one prescription for cimetidine, misoprostol, omeprazole, or ranitidine during the study period.
Main outcome measures : New occurrences of idiopathic gynaecomastia diagnosed by general practitioner.
Results : The relative risk of gynaecomastia for current users of cimetidine compared with non-users was 7.2 (95% confidence interval 4.5 to 11.3). Relative risks for misoprostol, omeprazole, and ranitidine were 2.0 (0.1 to 10.7), 0.6 (0.1 to 3.3), and 1.5 (0.8 to 2.6), respectively. Current users of cimetidine on a daily dose greater than equal to 1000 mg had more than 40 times the risk of developing gynaecomastia than non -users. The period of highest risk was seven to 12 months after starting cimetidine treatment. Spirono-lactone (relative risk 9.3 (3.3 to 26.1) and verapamil (9.7 (2.6 to 36.0)) were associated with a relative risk of gynaecomastia comparable to one for cimetidine.
Conclusions : Use of cimetidine, but not the three other antiulcer drugs, is associated with a substantially greater risk of gynaecomastia in men. A strong dose-response relation was present among cimetidine users.

Clinical implications

  • Clinical implications

  • Idiopathic gynaecomastia has been reported with many drugs, including cimetidine

  • No epidemiological study has examined the risk of gynaecomastia associated with various antiulcer medications

  • This study shows that use of cimetidine is associated with clinically important gynaecomastia but that use of misoprostol, omeprazole, and ranitidine is not

  • A strong dose-response relation is shown with use of cimetidine

  • Spironolactone and verapamil also present a large increased risk of developing gynaecomastia


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