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Safety

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Premarin (conjugated estrogens tablets, USP)


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

  • Ovarian Cancer

ADVERSE REACTIONS

  • Gastrointestinal
    • Ischemic Colitis
  • Central Nervous System
    • Possible growth potentiation of benign meningioma

PATIENT PACKAGE INSERT

  • What can I do to lower my chances of getting a serious side effect with Premarin?
    • If you have a uterus, talk with your healthcare provider...

WARNINGS

Malignant Neoplasms: Breast Cancer

The most important randomized clinical trial providing information about this issue in estrogen alone users is the Women’s Health Initiative (WHI) substudy of daily conjugated estrogens (CE 0.625 mg). In the estrogen alone substudy of WHI, after an average of 7.1 years of follow-up, daily CE 0.625 mg was not associated with an increased risk of invasive breast cancer ( relative risk [RR] 0.80, 95 percent nominal confidence interval [nCI] 0.62-1.04)...
    
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