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Oral contraceptives and venous thromboembolic disease, surgically confirmed gallbladder disease, and breast tumours. Report from the Boston Collaborative Drug Surveillance Programme.


 A large survey of 24 hospitals was conducted to identify associations between commonly used drugs and various diseases. The results of 3 such studies--on venous thromboembolism, gall bladder disease, and breast tumors--are summarized in this article. Trained nurses in various hospital wards interviewed admissions, asking questions designed to determine smoking behavior, coffee and tea drinking, drug use, marital status, and parity and menopausal status, where appropriate. This report specifically centers on associations between oral contraceptive use and development of the 3 conditions under study. Women reported on in this portion of the study were aged 20-44 years. Compared with nonusers, the estimate of relative risk for thromboembolism in users was 11, and the estimated attack rate attributable to oral contraceptives was 60/100,000 users/year. For gall bladder disease (surgically confirmed) the corresponding relative risk estimate was 2.0, and the estimated annual attack rate was 79/100,000. The frequency of gall bladder disease in women under 35 years was significantly higher in oral contraceptive users of 6-12 months duration, compared with women who had taken the pills for longer periods. Breast cancer studies showed no evidence of a higher risk in oral contraceptive users relative to nonusers. In fact, a negative association between oral contraceptive use and breast tumors was found, and this was more pronounced in women with fibroadenoma of the breast. Most of the women surveyed for this report took low-dose estrogen formulations, but the role of dose to the above findings was not investigated.
