Drug Alerts!

Estrogen & Progestin Drugs Given New Warnings

January 9, 2003 - MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The FDA and Wyeth Pharmaceuticals revised the prescribing information to include a boxed warning, which states that estrogens and estrogens plus progestin therapies should not be used for the prevention of cardiovascular disease.

The boxed warning includes risk information from the Women's Health Initiative (WHI) study. The study 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. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

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