Epogen (epoetin alfa) Procrit (epoetin alfa)

Published: Thu Dec 01 00:00:00 -0500 2005

Amgen, Ortho Biotech and FDA notified healthcare professionals of revision to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Epogen and Procrit. The revised labeling provides updated safety 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 these products. This has been reported predominantly in patients with CRF receiving these products by subcutaneous administration. Recommendations for evaluation and treatment are provided in the new prescribing information.