In response to the results of the Women's Health Initiative (WHI) study of the combination of conjugated equine estrogen/medroxyprogesterone acetate (Prempro), the FDA reminds physicians that the drug is currently approved for three indications: treatment of moderate-to-severe vasomotor symptoms associated with the menopause; treatment of vulvar and vaginal atrophy; and prevention of postmenopausal osteoporosis.
Although the stopped WHI study did not target symptomatic women or those at risk for osteoporotic complications, it does provide data on the long-term risks of Prempro in postmenopausal women. They include increased risks of breast cancer and thromboembolic disease associated with estrogen and combination estrogen/progestin therapy, as well as increased risk of cardiovascular disease, including myocardial infarction and stroke, in healthy women.
Crawford, Jr LM. FDA Statement on Prempro. JAMA. 2002;288(13):1579. doi:10.1001/jama.288.13.1579-JFD20010-3-1
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