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
