THE SAFETY OF INTRAVENOUS IRON DEXTRAN IN HEMODIALYSIS-PATIENTS

The treatment of anemia in hemodialysis patients is frequently hindere d by the presence of suboptimal iron stores. Intravenous iron dextran is in common use to maintain iron stores in this population, but there are little published data regarding the incidence and type of adverse events. The purpose of this study was to evaluate the safety of this medication. Charts from four hemodialysis centers of all 573 patients treated with intravenous iron dextran (INFeD; Schein Pharmaceutical, I nc, Florham Park, NJ) between July 1, 1993, and June 30, 1995, were st udied, Twenty-seven patients (4.7%) had adverse reactions that were re lated to iron dextran. Four patients (0.7%) had reactions classified a s serious (one cardiac arrest; three others required hospitalization). Ten patients (1.7%) had reactions classified as anaphylactoid. No pat ients died or developed permanent disability as a result of reactions. The most common adverse reactions included itching (1.5% of patients) and dyspnea or wheezing (1.5%); others included chest pain (1.0%), na usea (0.5%%), hypotension (0.5%), swelling (0.5%), dyspepsia (0.5%), d iarrhea (0.5%), skin flushing (0.3%), headache (0.3%), cardiac arrest (0.2%), and myalgias (0.2%). Five of all the reactions occurred during a test dose; four of these were anaphylactoid. Several factors were s tudied as possible predictors of adverse reactions. A positive history of drug allergy (odds ratio, 2.4; P = 0.03) and history of multiple d rug allergy (odds ratio, 5.5; P = 0.0004) were significant predictors of reactions. In summary, we found serious adverse reactions to be unc ommon in hemodialysis patients treated with intravenous iron dextran. Future prospective studies will help confirm this finding. (C) 1996 by the National Kidney Foundation, Inc.