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U.S. Department of Health and Human Services

Safety

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Abraxane Injectable Suspension (paclitaxel protein-bound particles (albumin-bound)) for injectable suspension

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

 

October 2013

Summary View

ADVERSE REACTIONS

Post-Marketing Experience with ABRAXANE and other Paclitaxel Formulations
  • Cardiovascular: There have been reports of congestive heart failure, left ventricular dysfunction, and atrioventricular block with ABRAXANE. Most of the individuals were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history.

 

 

June 2013

Summary View

 

ADVERSE REACTIONS

Clinical Trial Experience in Metastatic Breast Cancer
  • sepsis and neutropenic sepsis