Fortuny, Joan ORCID: 0000-0001-9401-5243, von Gersdorff, Gero, Lassalle, Regis ORCID: 0000-0001-6726-6215, Linder, Marie ORCID: 0000-0003-2619-2189, Overbeek, Jetty, Reinold, Jonas ORCID: 0000-0001-8266-2574, Toft, Gunnar ORCID: 0000-0002-7542-6853, Timmer, Antje ORCID: 0000-0001-9579-0516, Dress, Jochen, Blin, Patrick ORCID: 0000-0003-4005-7928, Droz-Perroteau, Cecile, Ehrenstein, Vera, Franzoni, Carla, Herings, Ron, Kollhorst, Bianca, Moore, Nicholas, Odsbu, Ingvild, Perez-Gutthann, Susana ORCID: 0000-0001-5798-3691, Schink, Tania, Rascher, Katherine, Rasouliyan, Lawrence, Rothman, Kenneth J., Saigi-Morgui, Nuria, Schaller, Mathias, Smits, Elisabeth, Forstner, Michael, Benichou, Jacques, Bircher, Andreas J., Garbe, Edeltraut, Rampton, David S. and Gutierrez, Lia ORCID: 0000-0001-6280-1119 (2021). Use of intravenous iron and risk of anaphylaxis: A multinational observational post-authorisation safety study in Europe. Pharmacoepidemiol. Drug Saf., 30 (10). S. 1447 - 1458. HOBOKEN: WILEY. ISSN 1099-1557

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Abstract

Purpose This post-authorisation safety study estimated the risk of anaphylaxis in patients receiving intravenous (IV) iron in Europe, with interest in iron dextran and iron non-dextrans. Studies conducted in the United States have reported risk of anaphylaxis to IV iron ranging from 2.0 to 6.8 per 10 000 first treatments. Methods Cohort study of IV iron new users, captured mostly through pharmacy ambulatory dispensing, from populations covered by health and administrative data sources in five European countries from 1999 to 2017. Anaphylaxis events were identified through an algorithm that used parenteral penicillin as a positive control. Results A total of 304 210 patients with a first IV iron treatment (6367 iron dextran), among whom 13-16 anaphylaxis cases were identified and reported as a range to comply with data protection regulations. The pooled unadjusted incidence proportion (IP) ranged from 0.4 (95% confidence interval [CI], 0.2-0.9) to 0.5 (95% CI, 0.3-1.0) per 10 000 first treatments. No events were identified at first dextran treatments. There were 231 294 first penicillin treatments with 30 potential cases of anaphylaxis (IP = 1.2; 95% CI, 0.8-1.7 per 10 000 treatments). Conclusion We found an IP of anaphylaxis from 0.4 to 0.5 per 10 000 first IV iron treatments. The study captured only a fraction of IV iron treatments administered in hospitals, where most first treatments are likely to happen. Due to this limitation, the study could not exclude a differential risk of anaphylaxis between iron dextran and iron non-dextrans. The IP of anaphylaxis in users of penicillin was consistent with incidences reported in the literature.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Fortuny, JoanUNSPECIFIEDorcid.org/0000-0001-9401-5243UNSPECIFIED
von Gersdorff, GeroUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lassalle, RegisUNSPECIFIEDorcid.org/0000-0001-6726-6215UNSPECIFIED
Linder, MarieUNSPECIFIEDorcid.org/0000-0003-2619-2189UNSPECIFIED
Overbeek, JettyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reinold, JonasUNSPECIFIEDorcid.org/0000-0001-8266-2574UNSPECIFIED
Toft, GunnarUNSPECIFIEDorcid.org/0000-0002-7542-6853UNSPECIFIED
Timmer, AntjeUNSPECIFIEDorcid.org/0000-0001-9579-0516UNSPECIFIED
Dress, JochenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blin, PatrickUNSPECIFIEDorcid.org/0000-0003-4005-7928UNSPECIFIED
Droz-Perroteau, CecileUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ehrenstein, VeraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Franzoni, CarlaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Herings, RonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kollhorst, BiancaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moore, NicholasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Odsbu, IngvildUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Perez-Gutthann, SusanaUNSPECIFIEDorcid.org/0000-0001-5798-3691UNSPECIFIED
Schink, TaniaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rascher, KatherineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rasouliyan, LawrenceUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rothman, Kenneth J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Saigi-Morgui, NuriaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schaller, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Smits, ElisabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Forstner, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Benichou, JacquesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bircher, Andreas J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Garbe, EdeltrautUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rampton, David S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gutierrez, LiaUNSPECIFIEDorcid.org/0000-0001-6280-1119UNSPECIFIED
URN: urn:nbn:de:hbz:38-604065
DOI: 10.1002/pds.5319
Journal or Publication Title: Pharmacoepidemiol. Drug Saf.
Volume: 30
Number: 10
Page Range: S. 1447 - 1458
Date: 2021
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 1099-1557
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
Public, Environmental & Occupational Health; Pharmacology & PharmacyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60406

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