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An event is serious (FDA MedWatch definition) when the patient outcome is:
* congenital anomaly
* requires intervention to prevent permanent impairment or damage
In a non-interventional, parallel-group, prospective immunogenicity surveillance registry of 15333 patients with chronic kidney disease (CKD), 5 patients aged 63-92 years were identified to have developed pure red cell aplasia (PRCA) during treatment with darbepoetin-α [aranesp] [1 patient], epoetin-α [eprex] [3 patients] and epoetin-β [neoRecormon] [1 patient]. This report involves patient 1 who developed PRCA with darbepoetin-α, patient 2 who developed PRCA with epoetin-β and patients 3, 4 and 5 developed PRCA with epoetin-α.
A 76-year-old man 1with stage 4 CKD, was started on SC darbepoetin-α 20 µg once weekly in August 2006 and maintained until August 2007, when the dose was increased to 20 µg twice weekly. His haemoglobin was 10.9 g/dL at...
- Macdougall IC, et al. Incidence of erythropoietin antibody-mediated pure red cell aplasia: The Prospective Immunogenicity Surveillance Registry (PRIMS). Nephrology Dialysis Transplantation 30: 451-460, No. 3, Mar 2015. Available from: URL: http://doi.org/10.1093/ndt/gfu297 - United KingdomCrossRefPubMedCentralGoogle Scholar