• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)

Audience: Reproductive healthcare professionals

FDA and Wyeth 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.

[January 6, 2003 - Letter - Wyeth] PDF Format
[January 2003 - Drug Information Page - FDA/CDER]

Past MedWatch Alerts:
[August 2002]