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High estrogen content oral contraceptives continued availability.

FDC Reports. Drugs and Cosmetics. 1980 Oct 27; 42(43):T and G-8.

The Fertility and Maternal Health Drugs Advisory Committee recently recommended the continued marketing of all current OC (oral contraceptives) doses on the market. It also recommends the revision of the labeling caution on "dose-related risk of thromboembolism from OC" to "studies have shown a possible (substituted for 'positive') association between the dose of estrogen in OCs and risk of thromboembolism". A cautionary statement on patient package labeling should indicate to the patient that doubling dose or side effects of breakthrough bleeding will result in higher amounts of estrogen. The recommendations were based on a review of high dose OC studies presented by Boston University. The review failed to conclusively establish the claim that higher dose estrogens are less safe than those containing smaller amounts of estrogen. Cited were the major findings of the Walnut Creek Contraceptive Drug Study, the most comprehensive prospective investigation of American OC users. The findings suggest that: 1) there is no evidence of an increase in risk of cancer of breast, endometrium or ovary associated with OC use; 2) OC use in itself does not increase risk of cervical cancer; 3) OC users who do not smoke do not have any increase in risk from circulatory disease; and 4) increase in risk of malignant melanoma of skin was associated with OC users of all ages.

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