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Hypersensitivity reactions associated with iron isomaltoside and ferric carboxymaltose

Published:November 30, 2022DOI:https://doi.org/10.1016/j.ejim.2022.11.030
      In 2013, the European Union (EU) ordered a review of all IV iron-containing medicines [ ], 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.
      ].

      Abbreviations:

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