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U.S. Department of Health and Human Services

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Arimidex (anastrozole) Tablets December 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- December 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. Read about the new physician labeling format.


 

Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Pregnancy and Premenopausal Women

WARNINGS AND PRECAUTIONS

  • Ischemic Cardiovascular Events

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Ischemic Cardiovascular Events

USE IN SPECIFIC POPULATIONS

  • Pregnancy

CONTRAINDICATIONS

Pregnancy and Premenopausal Women:

Arimidex may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. Arimidex is contraindicated in women who are or may become pregnant. There are no adequate and well-controlled studies in pregnant women using Arimidex. If Arimidex is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus or potential risk for loss of the pregnancy. [see Use in Specific Populations (8.1)]

WARNINGS AND PRECAUTIONS

Ischemic Cardiovascular Events:

In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with Arimidex in the ATAC trial (17% of patients on Arimidex and 10% of patients on tamoxifen). Consider risk and benefits of Arimidex therapy in patients with pre-existing ischemic heart disease. [see Adverse Reactions (6.1)]