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News From the Food and Drug Administration
October 2, 2002

FDA Statement on Prempro

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JAMA. 2002;288(13):1579. doi:10.1001/jama.288.13.1579-JFD20010-3-1

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.