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U.S. Department of Health and Human Services

Safety

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Adagen (pegademase bovine) Injection September 2008

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

ADVERSE REACTIONS

  • First Paragraph
    • The following adverse reactions were reported during clinical trials...
  • The following adverse reactions have been identified during post-approval use of Adagen (pegademase bovine) Injection...
    • Hematologic events: hemolytic anemia, auto-immune hemolytic anemia, thrombocythemia
    • Dermatological events: injection site erythema, urticaria