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Epoetin Alfa (Epogen®, Procrit®) and Darbepoetin Alfa (Aranesp®) - Associated with Pure Red Cell Aplasia

December 2, 2005

Amgen, OrthoBiotech, and FDA are warning practitioners of reports of pure red cell aplasia (PRCA), or anti-erythropoietin antibody-associated anemia, associated with use of erythropoietic agents (darbepoetin alfa [Aranesp], epoetin alfa [Epogen, Procrit]). Pure red cell aplasia is characterized by severe anemia and a low reticulocyte count. Most cases occurred in chronic renal failure patients receiving subcutaneous erythropoietic agents.  The product labeling has been revised to reflect this risk. 

Discontinue the erythropoietic agent immediately if PRCA is suspected. Contact the manufacturer at the following numbers to confirm the diagnosis: Amgen 1-800-772-6436; Ortho Biotech 1-800-325-7504, prompt #2. The manufacturer will conduct assays for binding and neutralizing antibodies. If antibody-mediated anemia is confirmed by the assays, permanently discontinue the erythropoietic agent.  Since cross-reactivity may occur, do not switch the patient to another erythropoietic agent. Additional information is available at the following links:

• MedWatch Alerts:
  • Epoetin alfa:
    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151170.htm
  • Darbepoetin alfa:
    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150646.htm
• Healthcare Professional Letters:
  • Epoetin alfa (Epogen):
    http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM164481.pdf
  • Epoetin alfa (Procrit):
    http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM164485.pdf
  • Darbepoetin alfa:
    http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM164147.pdf
• Revised Product Labeling:
  • Epoetin alfa (Epogen):
    http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103234s5093lbl.pdf
  • Epoetin alfa (Procrit):
    http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5196PI.pdf
  • Darbepoetin alfa:
    http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103951s5096lbl.pdf

Updated
December 2, 2005; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.