Adverse events in chronic hemodialysis patients receiving intravenous irondextran - A comparison of two products

Background: Parenteral iron therapy is required in a majority of chronic di alysis patients who are receiving recombinant human erythropoietin (r-HuEPO ) in order to provide adequate iron for erythropoiesis. At this time, there are only two formulations of parenteral iron dextran available for clinica l use in the USA. These two preparations of iron dextran have different phy sical and chemical characteristics that might affect the adverse events exp erienced by dialysis patients receiving iron dextran. Methods: We performed a retrospective analysis of all 665 courses of parenteral iron dextran whi ch were administered in our hemodialysis unit from June 1992 through July 1 997. An adverse event (AE) was defined as any event which led to interrupti on of the prescribed course of iron therapy or precluded subsequent adminis tration of parenteral iron in the presence of documented iron deficiency. D atabase elements included patient age, gender, cause of renal failure, and prior history of drug allergy. The average hemoglobin value and serum iron parameters (iron, total iron binding capacity (TIBC), percent saturation of TIBC, and ferritin) were recorded both pre- and post-iron administration, when available. A course of parenteral iron dextran consisted of a 25-mg te st dose, followed by four or five doses of 300 mg each. Iron dextran was in fused into the venous limb of the hemodialysis blood circuit over the last 30-60 min of a dialysis treatment. The two forms of iron dextran were desig nated as Iron A (molecular weight = 165,000) and Iron B (molecular weight = 267,000). Results: Fifty-seven percent of our patients were male, 92% were of white race, and diabetes was the most common cause of renal failure (34 %). Sixty four percent of the patients were 60 years of age or older, and 3 9% had a history of allergy to one or more drugs. We observed 33 AEs during the administration of parenteral iron dextran, and these AEs occurred in 2 1 courses of parenteral iron dextran administration. Eighteen of the AEs we re gastrointestinal in nature; 7 AEs were cutaneous in nature, 6 AEs had sy stemic manifestations, while only 2 AEs caused respiratory problems. Two of the AEs were felt to be anaphylactoid in nature. Female gender (p = 0.06) and iron dextran product (p = 0.02) were identified as potential risk facto rs for the development of an AE. There were 468 courses of Iron A administe red, 10 of these courses were complicated by 15 AEs (one or more AE per cou rse). One hundred and ninety-seven courses of Iron B were administered and 11 (5.6%) courses were complicated by the development of 18 AEs (9.1 AEs pe r 100 courses). Serum iron rose by 22 mug/dl and TIBC saturation increased by 14% after the administration of parenteral iron. The average serum ferri tin level rose by 430 mug/l and hemoglobin values rose by an average of 0.8 g/dl. There were no significant differences in the changes of iron paramet ers or hemoglobin levels between the two iron dextran preparations. Conclus ions: The administration of parenteral iron dextran to chronic hemodialysis patients has a relatively high degree of safety. Both iron products were e qually efficacious in increasing serum iron parameters and hemoglobin level s. Even when corrected for other factors, there was a significant differenc e in the observed AEs between the two formulations of parenteral iron dextr an. Our observations, if true, may have important implications for the mana gement of anemia in chronic hemodialysis patients. If a significant number of AEs prohibit the administration of a specific iron dextran product to a large number of chronic hemodialysis patients, then anemia management may b ecome suboptimal. In the future, newer iron products may provide even safer alternatives for the administration of parenteral iron to chronic hemodialysis patients. Cop yright (C) 2000 S. Karger AG, Basel.