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

Safety

  • Print
  • Share
  • E-mail

Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Malignant Neoplasms
    • Breast Cancer

PRECAUTIONS

  • General
    • Ovarian Cancer
  • Nursing Mothers
    • ...Prempro and Premphase should not be used during lactation.
  • Pediatric Use
    • ...no clinicial data have been collected in children.
  • Geriatric Use

ADVERSE REACTIONS

  • Genitourinary System
    • Dysmenorrhea/Pelvic Pain
  • Central Nervous System (CNS)
    • Exacerbation of Chorea

WARNINGS

Malignant Neoplasms: Breast Cancer

The most important randomized clinical trial providing information about this issue in estrogen plus progestin users is the Women’s Health Initiative (WHI) substudy of daily conjugated estrogens (CE 0.625 mg) plus medroxyprogesterone acetate (MPA 2.5 mg). In the estrogen plus progestin substudy, after a mean follow-up of 5.6 years, the WHI substudy reported an increased risk of breast cancer in women who took daily CE/MPA...