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U.S. Department of Health and Human Services


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Avastin (bevacizumab) for Intravenous Use

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


  • Congestive Heart Failure


  • Metastatic Breast Cancer
    • Table 9 - Study 7


Congestive Heart Failure

...In Study 7, the rate of congestive heart failure (defined as NCI-CTC Grade 3 and 4) in the Avastin plus paclitaxel arm was 2.2% versus 0.3% in the control arm. Among patients receiving anthracyclines, the rate of CHF was 3.8% for Avastin treated patients and 0.6% for patients receiving paclitaxel alone...


Label approved 02/22/2008 is not available on Drugs@FDA