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Use of IV Iron and Risk of Anaphylaxis: A Multinational Observational Post-Authorisation Safety Study in Europe

dc.rights.licenseopenen_US
dc.contributor.authorFORTUNY, Joan
dc.contributor.authorVON GERSDORFF, Gero
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorLASSALLE, Regis
dc.contributor.authorLINDER, Marie
dc.contributor.authorOVERBEEK, Jetty
dc.contributor.authorREINOLD, Jonas
dc.contributor.authorTOFT, Gunnar
dc.contributor.authorTIMMER, Antje
dc.contributor.authorDRESS, Jochen
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBLIN, Patrick
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorDROZ-PERROTEAU, Cecile
dc.contributor.authorEHRENSTEIN, Vera
dc.contributor.authorFRANZONI, Carla
dc.contributor.authorHERINGS, Ron
dc.contributor.authorKOLLHORST, Bianca
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorMOORE, Nicholas
dc.contributor.authorODSBU, Ingvild
dc.contributor.authorPEREZ-GUTTHANN, Susana
dc.contributor.authorSCHINK, Tania
dc.contributor.authorRASCHER, Katherine
dc.contributor.authorRASOULIYAN, Lawrence
dc.contributor.authorROTHMAN, Kenneth J.
dc.contributor.authorSAIGI-MORGUI, Nuria
dc.contributor.authorSCHALLER, Mathias
dc.contributor.authorSMITS, Elisabeth
dc.contributor.authorFORSTNER, Michael
dc.contributor.authorCONSORTIUM, II
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBENICHOU, Jacques
dc.contributor.authorBIRCHER, Andreas J.
dc.contributor.authorGARBE, Edeltraut
dc.contributor.authorRAMPTON, David S.
dc.contributor.authorGUTIERREZ, Lia
dc.date.accessioned2021-07-15T15:07:33Z
dc.date.available2021-07-15T15:07:33Z
dc.date.issued2021-06-28
dc.identifier.issn1053-8569en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/109269
dc.description.abstractEnPURPOSE: 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.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subject.enAnaphylaxis
dc.subject.enCohort study
dc.subject.enDextran
dc.subject.enIV iron
dc.subject.enMultidatabase
dc.subject.enSevere hypersensitivity reactions
dc.title.enUse of IV Iron and Risk of Anaphylaxis: A Multinational Observational Post-Authorisation Safety Study in Europe
dc.typeArticle de revueen_US
dc.identifier.doi10.1002/pds.5319en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed34181291en_US
bordeaux.journalPharmacoepidemiology and Drug Safetyen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03287566
hal.version1
hal.date.transferred2021-07-15T15:07:39Z
hal.exporttrue
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