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      Safety of Iron Sucrose in Hemodialysis Patients Intolerant to Other Parenteral Iron Products

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          Background/Aims: This report summarizes the data gathered in four prospective studies of intravenous iron sucrose therapy administered to iron-deficient hemodialysis patients with a history of intolerance to other parenteral iron preparations. Methods: A total of 130 iron dextran- and/or sodium ferric gluconate-sensitive patients received intravenous iron sucrose therapy to correct iron deficiency, and/or maintain body iron stores. A history of intolerance to iron dextran alone was reported in 109 patients, to ferric sodium gluconate alone in 6 patients, and to both iron dextran and ferric sodium gluconate in 15 patients. Therapy with iron sucrose consisted of 100- or 200-mg doses administered undiluted intravenously over 2–5 min, or diluted in normal saline and infused over 15–30 min. Test doses of iron sucrose were not administered. The median cumulative dose was 1,000 mg, with a range of 100–5,000 mg. Results: There were no serious adverse events related to iron sucrose therapy in the 130 patients intolerant to other iron preparations. There were 14 nonserious drug-related adverse events in 8 patients attributed to iron sucrose, none of which resulted in discontinuation of therapy. These events were classified as either of severe (diarrhea), moderate (hypotension, nausea, vomiting), or mild severity (constipation, dry mouth, skin irritation). Conclusion: Iron sucrose therapy is safe and well tolerated in hemodialysis patients intolerant to iron dextran and/or sodium ferric gluconate.

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          Sodium ferric gluconate complex in hemodialysis patients: adverse reactions compared to placebo and iron dextran.

          Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores. Until recently, the only available form of intravenous iron was iron dextran, which is associated with significant adverse reactions, including anaphylaxis and death. Sodium ferric gluconate complex (SFGC) was recently approved for use in the U.S. under FDA's priority drug review. This Phase IV study was designed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control. This multicenter, crossover, randomized, double blind, placebo-controlled prospective comparative study was performed in hemodialysis patients requiring at least 125 mg of elemental iron. The historical control was obtained from a meta-analysis of four publications examining outcomes in patients exposed to iron dextran. SFGC naïve patients were administered SFGC without a test dose, undiluted, at a rate of 125 mg over 10 minutes, and compared to placebo comprising bacteriostatic saline. A total of 2534 patients were enrolled. The incidence of drug intolerance (an adverse event precluding re-exposure) was significantly less [0.44%, confidence interval (CI) 0.21 to 0.71%] after SFGC as compared to the iron dextran control (2.47%, CI 1.87 to 3.07%, P < 0.0001), but higher than after placebo (0.1%, P = 0.02). There was no difference found between SFGC and placebo in serious adverse events. A single life-threatening event occurred after SFGC (0.04%, CI 0.00 to 0.22%), which was significantly less than following iron dextran (0.61%, CI 0.36 to 0.86%), P = 0.0001. SFGC is well tolerated when given by intravenous push without a test dose. SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran. The routine use of iron dextran in hemodialysis patients should be discontinued.
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            Lack of reaction to ferric gluconate in hemodialysis patients with a history of severe reaction to iron dextran.

            Iron deficiency is the most common cause of a poor response to recombinant human erythropoietin (rHuEPO) in patients receiving long-term dialysis, who are known to absorb oral iron preparations poorly. This retrospective case series reports our preliminary observation of five patients receiving long-term dialysis in a tertiary care university hospital who had responded poorly to rHuEPO because of iron deficiency. These patients also had a history of severe, potentially life-threatening reaction to intravenous iron dextran preparation, but they tolerated the newly available ferric gluconate complex in sucrose with no untoward effects. These results suggest that the parenteral administration of ferric gluconate can be safe for those who require iron therapy and who have had a severe reaction to iron dextran.

              Author and article information

              Nephron Clin Pract
              Nephron Clinical Practice
              S. Karger AG
              February 2004
              17 November 2004
              : 96
              : 2
              : c63-c66
              Division of Nephrology and Hypertension, New York Hospital Medical Center of Queens, Flushing, N.Y., USA
              76401 Nephron Clin Pract 2004;96:c63–c66
              © 2004 S. Karger AG, Basel

              Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

              Page count
              Tables: 2, References: 9, Pages: 1
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              Original Paper

              Cardiovascular Medicine, Nephrology

              Iron dextran, Hemodialysis, Sodium ferric gluconate, Iron sucrose


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