Suspected iron dextran-related adverse drug events in hemodialysis patients

摘要: Despite the use of recombinant erythropoietin, anemia remains a significant problem for patients with end-stage renal disease, in part related to chronic dialysis-related blood loss and resultant iron deficiency. Because oral preparations have been relatively ineffective poorly tolerated this population, intravenous (IV) dextran has widely prescribed, despite finite risk adverse effects associated its use. We analyzed data from Fresenius Medical Care North America (FMCNA) clinical variance reports determine incidence suspected dextran-related drug events (ADEs) patient characteristics, dialysis practice patterns, outcomes. used case-cohort study design, comparing individuals who experienced ADEs overall FMCNA population. Among 841,252 IV administrations October 1998 through March 1999, there were 165 reported ADEs, corresponding an rate 0.000196%, or approximately 20 per 100,000 doses. Forty-three (26%) required independent emergency department evaluation, 18 (11%) hospitalization, 1 (0.6%) died. Dyspnea (43%), hypotension (23%), neurological symptoms (23%) most common major ADEs; nausea (34%), vomiting flushing (27%), pruritus (25%) other ADEs. 8.1-fold more among administered Dexferrum (American Regent Laboratories, Inc, Shirley, NY) compared those InFed (Watson Pharmaceuticals, Phoenix, AZ). In summary, serious reactions are rare practice. The appears depend on specific formulation dextran. Otherwise, difficult predict.