Suspected iron dextran-related adverse drug events in hemodialysis patients

Despite the use of recombinant erythropoietin, anemia remains a significant problem for patients with end-stage renal disease, in part related to chro nic dialysis-related blood loss and resultant iron deficiency. Because oral iron preparations have been relatively ineffective and poorly tolerated in this population, intravenous (IV) iron dextran has been widely prescribed, despite a finite risk for adverse effects associated with its use. We anal yzed data from Fresenius Medical Care North America (FMCNA) clinical varian ce reports to determine the incidence of suspected iron dextran-related adv erse drug events (ADEs) and associated patient characteristics, dialysis pr actice patterns, and outcomes. We used a case-cohort study design, comparin g individuals who experienced suspected ADEs with the overall FMCNA populat ion. Among 841,252 IV iron dextran administrations from October 1998 throug h March 1999, there were 165 reported suspected ADEs, corresponding to an o verall rate of 0.000196%, or approximately 20 per 100,000 doses. Forty-thre e patients (26%) required an independent emergency department evaluation, 1 8 patients (11%) required hospitalization, and 1 patient (0.6%) died. Dyspn ea (43%), hypotension (23%). and neurological symptoms (23%) were the most common major ADEs; nausea (34%), vomiting (23%), flushing (27%), and prurit us (25%) were the most common other ADEs. ADEs were 8.1-fold more common am ong patients administered Dexferrum (American Regent Laboratories, Inc, Shi rley, NY) compared with those administered InFed (Watson Pharmaceuticals, P hoenix, AZ). In summary, serious adverse reactions to IV iron dextran are r are in clinical practice. The risk appears to depend on the specific formul ation of IV iron dextran. Otherwise, iron dextran-related ADEs are difficul t to predict. (C) 2001 by the National Kidney Foundation, Inc.