Safety Labeling updates and new warnings


The labeling for darbepoetin alfa (Aranesp, Amgen) and epoetin alfa (Epogen, Amgen and Procrit, Ortho Biotech) was revised to include information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with the agents. This has been reported predominantly in patients with chronic renal failure receiving these products by subcutaneous administration.

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