| Subject: | Revisions to Warnings, Precautions, Adverse Reactions and Dosage and Administration Sections of the Pescribing Information for Aranesp, Epogen, and Procrit |
| Category: | Food and Drug Administration (FDA)
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| Published: | Wed, 7 Dec 2005 - 11:43 am |
| Amgen, Ortho Biotech and FDA have notified healthcare professionals of revision to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Aranesp, Epogen and Procrit.
The revised labeling provides updated safety information on reports of pure red cell aplasia, PRCA, and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with these products.
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