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Prempro

[Conjugated Estrogens/Medroxyprogesterone]

If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.

2. Malignant neoplasms.

a. Breast cancer.

Text Continues Below



Estrogen/ progestin therapy in postmenopausal women has been associated with an increased risk of breast cancer. In the PREMPRO substudy of the Women's Health Initiative study, a 26% increase of invasive breast cancer (38 vs 30 per 10,000 woman-years) after an average of 5.2 years of treatment was observed in women receiving PREMPRO compared to women receiving placebo.

The increased risk of breast cancer became apparent after 4 years on PREMPRO. The women reporting prior postmenopausal use of estrogen and/ or estrogen with progestin had a higher relative risk for breast cancer associated with PREMPRO than those who had never used these hormones. (See CLINICAL PHARMACOLOGY,
Clinical Studies.)

Epidemiologic studies have reported an increased risk of breast cancer in association with increasing duration of postmenopausal treatment with estrogens, with or without progestin. This association was reanalyzed in original data from 51 studies that involved treatment with various doses and types of estrogens, with and without progestin. In the reanalysis, an increased risk of having breast cancer diagnosed became apparent after about 5 years of continued treatment, and subsided after treatment had been discontinued for about 5 years. Some later studies have suggested that treatment with estrogen and progestin increases the risk of breast cancer more than treatment with estrogen alone.

A postmenopausal woman without a uterus who requires estrogen should receive estrogen-alone therapy and should not be exposed unnecessarily to progestins. All postmenopausal women should receive yearly breast exams by a healthcare provider and perform monthly breast self-examinations.

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