FDA Warning on Prempro

by Luise Light on July 23, 2008

Conjugated equine estrogens in Prempro are produced from the urine of pregnant mares, hence the product name  Prempro. Prempro is combined with a synthetic progestin, medroxyprogesterone acetate. Starting in January 2003, the FDA required Wyeth to start affixing this ‘black box’ warning on Prempro patient inserts.

WARNING

Estrogens and progestins should not be used for the prevention of cardiovascular disease. The Women’s Health Initiative (WHI) reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with conjugated equine estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations of estrogens and progestins were not studied in the WHI …

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