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    New warnings about Aranesp, Epogen and Procrit December 2, 2005 - Amgen, Ortho Biotech and the FDA notified healthcare professionals of revision to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa). 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 chronic renal failure receiving these products by subcutaneous administration. Recommendations for evaluation and treatment are provided in the new prescribing information.
Patients taking Epogen, Procrit or Aranesp should NOT discontinue taking their medication before speaking with their physician.
Questions or concerns regarding this important safety information can be directed to Amgen medical department at 1-800-11-Amgen or Ortho Biotech at 1-800-325-7504. As always, pharmacies and members can also contact the RxAmerica customer service desk at 1-800-770-8014 if they have any questions about this new product warning. |
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