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Letter to the Editor|Articles in Press

Hypersensitivity reactions associated with iron isomaltoside and ferric carboxymaltose

Published:November 30, 2022DOI:https://doi.org/10.1016/j.ejim.2022.11.030
Hypersensitivity reactions associated with iron isomaltoside and ferric carboxymaltose
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      In 2013, the European Union (EU) ordered a review of all IV iron-containing medicines [

      EMA-CHMP report, 2020: https://www.ema.europa.eu/en/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-assessment-report_en.pdf.

      ], and subsequently requested that a post-authorization study (EUPASS20720) be conducted to further assess safety concerns related to hypersensitivity reactions. This study analyzed 304,210 IV iron treatments, showing an incidence of anaphylaxis of between 0.4 and 0.5 per 10,000 in non-dextran IV iron treatments. However, it was unable to find differences in hypersensitivity reactions, even between dextran IV and non-dextran irons or between the various non-dextran irons [
      • Fortuny J.
      • Von Gersdorff G.
      • Lassalle R.
      • Linder M.
      • Overbeek J.
      • Reinold J.
      • et al.
      Use of intravenous iron and risk of anaphylaxis: a multinational observational post-authorisation safety study in Europe.
      Pharmacoepidemiol Drug Saf. 2021; 30: 1447-1457
      ].

      Abbreviations:

      IV (intravenous), ICD (International Classification of Diseases), MedDRA (Medical Dictionary for Regulatory Activities Terminology)
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      References

      1. EMA-CHMP report, 2020: https://www.ema.europa.eu/en/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-assessment-report_en.pdf.

        View in Article
        • Fortuny J.
        • Von Gersdorff G.
        • Lassalle R.
        • Linder M.
        • Overbeek J.
        • Reinold J.
        • et al.
        Use of intravenous iron and risk of anaphylaxis: a multinational observational post-authorisation safety study in Europe.
        Pharmacoepidemiol Drug Saf. 2021; 30: 1447-1457
        View in Article
        • Wolf M.
        • Rubin J.
        • Achebe M.
        • Econs M.J.
        • Peacock M.
        • Imel E.A.
        • et al.
        Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-deficiency Anemia.
        JAMA. 2020; 323: 432-443
        View in Article
        • Pollock R.F.
        • Biggar P.
        Indirect methods of comparison of the safety of ferric derisomaltose, iron sucrose and ferric carboxymaltose in the treatment of iron deficiency anemia.
        Expert Rev Hematol. 2020; 13: 187-195
        View in Article

      5. AEMPS report, 2020: https://www.aemps.gob.es/informa/notasinformativas/medicamentosusohumano-3/seguridad-1/2017/ni-muh_fv_08-2017-hierro_isomaltosido/.

        View in Article
        • Ring J.
        • Messmer K.
        Incidence and severity of anaphylactoid reactions to colloid volume substitutes.
        Lancet. 1977; 309: 466-469
        View in Article
        • Bager P.
        • Hvas C.L.
        • Dahlerup J.F.
        Drug-specific hypophosphatemia and hypersensitivity reactions following different intravenous iron infusions.
        Br J Clin Pharmacol. 2017; 83: 1118-1125
        View in Article
        • Mulder M.B.
        • Van den Hoek H.L.
        • Birinie E.
        • Van Tilburg A.J.P.
        • Westerman E.M.
        Comparison of hypersensitivity reactions of intravenous iron: iron isomaltoside-1000 (Monofer®) versus ferric carboxy-maltose (Ferinject®). A single center, cohort study.
        Br J Clin Pharmacol. 2019; 85: 385-392
        View in Article
        • Critchly J.
        • Dunbar Y.
        Adverse events associated with intravenous iron infusion (low-molecular-weight iron dextran and iron sucrose): a systematic review.
        Transfus Altern Transfus Med. 2007; 9: 8-36
        View in Article
        • Szebeni J.
        • Fishbane S.
        • Hedenus M.
        • Howaldt S.
        • Locatelli F.
        • Patni S.
        • et al.
        Hypersensitivity to intravenous iron: classification, terminology, mechanisms and management.
        Br J Pharmacol. 2015; 172: 5025-5036
        View in Article

      Article info

      Publication history

      Published online: November 30, 2022
      Accepted: November 24, 2022
      Received in revised form: November 22, 2022
      Received: November 11, 2022

      Publication stage

      In Press Corrected Proof

      Identification

      DOI: https://doi.org/10.1016/j.ejim.2022.11.030

      Copyright

      © 2022 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

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