Label Changes for:

Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets

February 2012

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012

 

CONTRAINDICATIONS

  • known anaphylactic reaction or angioedema and known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

WARNINGS AND PRECAUTIONS

  • anaphylactic reaction and angioedema
  • hereditary angioedema

ADVERSE REACTIONS

Postmarketing Experience
  • ischemic colitis
  • growth potentiation of benign meningioma

PATIENT PACKAGE INSERT

  • Revisions with the addition of have been diagnosed with a bleeding disorder

 

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