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Revised Labeling for Aranesp, Epogen, and Procrit Provides Updated Safety Information About Pure Red Cell Aplasia and Severe Anemia

December 1, 2005 -- ROCKVILLE, MD -- 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 these three products. 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.

Read the complete MedWatch 2005 Safety summary, including links to the Dear Healthcare Professional letters and revised prescribing information at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm

and

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm.

Source: The Food and Drug Administration

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