Literature DB >> 30393904

Comparison of hypersensitivity reactions of intravenous iron: iron isomaltoside-1000 (Monofer® ) versus ferric carboxy-maltose (Ferinject® ). A single center, cohort study.

Midas B Mulder1, Hester L van den Hoek2,3, Erwin Birnie4,5, Antonie J P van Tilburg6, Elsbeth M Westerman1.   

Abstract

AIMS: Intravenous iron supplementation is widely used to treat iron deficiency and iron deficiency anemia when oral iron administration is ineffective or poorly tolerated. Hypersensitivity reactions (HSRs) during infusions are rare, but can be life-threatening. This study aimed to compare the risk for HSRs with the intravenous administration of iron isomaltoside-1000 and ferric carboxymaltose for the treatment of iron deficiency and iron deficiency anemia.
METHODS: This was a single-centre cohort study. Nurses and physicians were instructed to fill out an HSR registration form with every administration of intravenous iron. HSRs were distinguished into serious and non-serious HSRs using the Ring and Messmer classification.
RESULTS: HSRs occurred in 18/836 (2.1%) ferric carboxymaltose and 43/496 (8.7%) iron isomaltoside-1000 administrations. The crude risk for HSRs was 75% lower after ferric carboxymaltose treatment (RR = 0.248, 95% CI: 0.145-0.426, P < 0.0001). The risk for grade II HSRs was 88% lower after ferric carboxymaltoside (RR = 0.123, 95% CI: 0.051-0.294). The likelihood of HSRs was 3.4 times higher after the administration of iron isomaltoside-1000 (95% CI: 1.910-6.093, P < 0.0001). Regardless of the type of intravenous iron, patients with comorbidities have a factor 3.6 higher risk (95% CI: 1.899-6.739, P < 0.0001).
CONCLUSIONS: Ferric carboxymaltose is associated with a 75% lower risk for HSRs compared with iron isomaltoside-1000 in our population. The presence of a comorbidity raises the likelihood of an HSR by a factor of three regardless of the type of intravenous iron infusion. Further research is needed to clarify the underlying mechanism in various patient groups.
© 2018 The British Pharmacological Society.

Entities:  

Keywords:  anemia; intravenous iron; iron deficiency; safety

Mesh:

Substances:

Year:  2018        PMID: 30393904      PMCID: PMC6339965          DOI: 10.1111/bcp.13805

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN: 0306-5251            Impact factor:   4.335


  19 in total

Review 1.  The efficacy and safety of current intravenous iron preparations for the management of iron-deficiency anaemia: a review.

Authors:  Wajeh Y Qunibi
Journal:  Arzneimittelforschung       Date:  2010

2.  Comparison of hypersensitivity reactions of intravenous iron: iron isomaltoside-1000 (Monofer® ) versus ferric carboxy-maltose (Ferinject® ). A single center, cohort study.

Authors:  Midas B Mulder; Hester L van den Hoek; Erwin Birnie; Antonie J P van Tilburg; Elsbeth M Westerman
Journal:  Br J Clin Pharmacol       Date:  2018-12-11       Impact factor: 4.335

3.  Structure, chemistry, and pharmacokinetics of intravenous iron agents.

Authors:  Bo G Danielson
Journal:  J Am Soc Nephrol       Date:  2004-12       Impact factor: 10.121

Review 4.  Iron-deficiency anemia.

Authors:  Clara Camaschella
Journal:  N Engl J Med       Date:  2015-05-07       Impact factor: 91.245

Review 5.  The safety of intravenous iron preparations: systematic review and meta-analysis.

Authors:  Tomer Avni; Amir Bieber; Alon Grossman; Hefziba Green; Leonard Leibovici; Anat Gafter-Gvili
Journal:  Mayo Clin Proc       Date:  2014-10-30       Impact factor: 7.616

6.  Drug-specific hypophosphatemia and hypersensitivity reactions following different intravenous iron infusions.

Authors:  Palle Bager; Christian L Hvas; Jens F Dahlerup
Journal:  Br J Clin Pharmacol       Date:  2017-01-18       Impact factor: 4.335

Review 7.  Clinical use of intravenous iron: administration, efficacy, and safety.

Authors:  Michael Auerbach; Harold Ballard
Journal:  Hematology Am Soc Hematol Educ Program       Date:  2010

8.  Incidence and severity of anaphylactoid reactions to colloid volume substitutes.

Authors:  J Ring; K Messmer
Journal:  Lancet       Date:  1977-02-26       Impact factor: 79.321

9.  A method for estimating the probability of adverse drug reactions.

Authors:  C A Naranjo; U Busto; E M Sellers; P Sandor; I Ruiz; E A Roberts; E Janecek; C Domecq; D J Greenblatt
Journal:  Clin Pharmacol Ther       Date:  1981-08       Impact factor: 6.875

10.  Immunologic studies of anaphylaxis to iron dextran in patients on renal dialysis.

Authors:  H S Novey; M Pahl; I Haydik; N D Vaziri
Journal:  Ann Allergy       Date:  1994-03
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  7 in total

1.  Comparison of hypersensitivity reactions of intravenous iron: iron isomaltoside-1000 (Monofer® ) versus ferric carboxy-maltose (Ferinject® ). A single center, cohort study.

Authors:  Midas B Mulder; Hester L van den Hoek; Erwin Birnie; Antonie J P van Tilburg; Elsbeth M Westerman
Journal:  Br J Clin Pharmacol       Date:  2018-12-11       Impact factor: 4.335

2.  Authors' reply to Schaffalitzky de Muckadell and colleague's Comment on "Evaluation of the Reported Rates of Severe Hypersensitivity Reactions Associated with Ferric Carboxymaltose and Iron (III) Isomaltoside 1000 in Europe Based on Data from EudraVigilance and VigiBase™ between 2014 and 2017".

Authors:  Birgit Ehlken; Lennart Nathell; Annegret Gohlke; Derya Bocuk; Massoud Toussi; Stefan Wohlfeil
Journal:  Drug Saf       Date:  2019-05       Impact factor: 5.606

3.  Evaluation of the Reported Rates of Severe Hypersensitivity Reactions Associated with Ferric Carboxymaltose and Iron (III) Isomaltoside 1000 in Europe Based on Data from EudraVigilance and VigiBase™ between 2014 and 2017.

Authors:  Birgit Ehlken; Lennart Nathell; Annegret Gohlke; Derya Bocuk; Massoud Toussi; Stefan Wohlfeil
Journal:  Drug Saf       Date:  2019-03       Impact factor: 5.606

4.  Oral iron supplementation with ferric maltol in patients with pulmonary hypertension.

Authors:  Karen M Olsson; Jan Fuge; Torben Brod; Jan C Kamp; Jan Schmitto; Tibor Kempf; Johann Bauersachs; Marius M Hoeper
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5.  Safety and efficacy of a single total dose infusion (1020 mg) of ferumoxytol.

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Journal:  Ther Adv Hematol       Date:  2021-04-12

6.  Fatal anaphylactic reaction due to ferric carboxymaltose: A case report.

Authors:  Aylin Mualla Arici; Zeynep Kumral; Ayşe Gelal; Bahri Akdeniz
Journal:  Anatol J Cardiol       Date:  2020-08       Impact factor: 1.596

7.  Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures.

Authors:  Lennart Nathell; Annegret Gohlke; Stefan Wohlfeil
Journal:  Drug Saf       Date:  2020-01       Impact factor: 5.606

  7 in total

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