Adverse Events in Chronic Hemodialysis Patients Receiving Intravenous Iron Dextran – A Comparison of Two Products

Abstract

Background: Parenteral iron therapy is required in a majority of chronic dialysis 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 clinical use in the USA. These two preparations of iron dextran have different physical and chemical characteristics that might affect the adverse events experienced by dialysis patients receiving iron dextran. Methods: We performed a retrospective analysis of all 665 courses of parenteral iron dextran which were administered in our hemodialysis unit from June 1992 through July 1997. An adverse event (AE) was defined as any event which led to interruption of the prescribed course of iron therapy or precluded subsequent administration of parenteral iron in the presence of documented iron deficiency. Database 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 test dose, followed by four or five doses of 300 mg each. Iron dextran was infused 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 designated 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 39% 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 21 courses of parenteral iron dextran administration. Eighteen of the AEs were gastrointestinal in nature; 7 AEs were cutaneous in nature, 6 AEs had systemic 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 factors for the development of an AE. There were 468 courses of Iron A administered, 10 of these courses were complicated by 15 AEs (one or more AE per course). 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 per 100 courses). Serum iron rose by 22 µg/dl and TIBC saturation increased by 14% after the administration of parenteral iron. The average serum ferritin level rose by 430 µg/l and hemoglobin values rose by an average of 0.8 g/dl. There were no significant differences in the changes of iron parameters or hemoglobin levels between the two iron dextran preparations. Conclusions: The administration of parenteral iron dextran to chronic hemodia...

The Comparative Safety of Various Intravenous Iron Preparations in Chronic Kidney Disease Patients

“…One of the two patients with anaphylactoid reaction and the sole patient with anaphylaxis had shown sensitivity to imferon in the past, thereby suggesting a high cross-reactivity between dextran compounds of different molecular weight. Non-serious ADEs rates with ID were 15.92% per patient and 1.76% per exposure, which is similar to the studies of McCarthy et al [16] (12.2% per patient) and Barton [14] (13% per patient). We have included patients developing respiratory tract infection in view of the suspected toxic effects of parenteral iron on the host-defense mechanisms.…”

Clinical Use of Intravenous Iron: Administration, Efficacy, and Safety

“…In a review of suspected iron dextran AEs, Fletes et al 34 noted that AEs were 8.1 times more likely to occur with HMW ID, and concluded that serious AEs related to IV iron dextran were rare and appeared to depend on the specific formulation of IV iron dextran. Similar results were observed by McCarthy et al 35 in a study examining AEs in chronic hemodialysis patients receiving IV iron dextran. In the first study to demonstrate the benefit of IV iron in synergizing with ESAs in the management of chemotherapyinduced anemia, 81 of 157 patients received iron dextran either as a bolus or TDI.…”

How I treat anemia in pregnancy: iron, cobalamin, and folate

“…HMW iron dextran has been linked to an increased risk of anaphylaxis and is no longer available. 65 An observational study of 189 women treated with LMW iron dextran in second and third trimester reported no severe adverse events and only 2% transient infusion reactions. 66 These results corroborated outcomes in other studies showing safety of LMW iron dextran, 67,68 which allows complete replacement of IV iron in a single infusion over 15 to 60 minutes.…”