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  Vol. 288 No. 13, October 2, 2002 TABLE OF CONTENTS
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FDA Statement on Prempro

JAMA. 2002;288:1579.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Women taking Prempro or other combination estrogen/progestin therapy should consult with their physicians about the relevance of this new information to their treatment. Because of differences in estrogenic potency and product composition, it . . . [Full Text of this Article]



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