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Although uncommon, administration of modern IV iron formulations can result in hypersensitivity reactions (HSRs) and, rarely, anaphylactic or anaphylactoid reactions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>The objective of the present study was to systematically review the literature to identify and analyze data on the incidence of HSRs after administration of ferric derisomaltose (FDI) or ferric carboxymaltose (FCM).<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>A prospectively-registered systematic literature review was conducted to identify prospective randomized controlled trials comparing FDI and FCM with other intravenous iron formulations or oral iron. Searches were conducted in PubMed (including MEDLINE), EMBASE, and the Cochrane Library in November 2020. The relative incidence of serious or severe HSRs occurring on the day or day after dosing of intravenous iron, recorded under the standardized Medical Dictionary for Regulatory Activities query for anaphylactic reaction.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Data were obtained from seven randomized controlled trials of FCM (N\u2009=\u20092683) and ten of FDI (N\u2009=\u20093474) enrolling 10,467 patients in total. The number of patients experiencing any serious or severe HSR event was 29\/2683 (1.08%) with FCM versus 5\/3474 with FDI (0.14%). Bayesian inference of proportions showed the event rates to be significantly lower with FDI relative to FCM.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>HSR events were uncommon with both intravenous iron formulations; however, the present study showed a significantly lower incidence of HSRs with FDI relative to FCM. Further large-scale, head-to-head trials of the iron formulations would be required to confirm this finding.<\/jats:p><\/jats:sec>","DOI":"10.1007\/s11096-023-01548-2","type":"journal-article","created":{"date-parts":[[2023,4,3]],"date-time":"2023-04-03T12:28:46Z","timestamp":1680524926000},"page":"604-612","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["A systematic literature review and meta-analysis of the incidence of serious or severe hypersensitivity reactions after administration of ferric derisomaltose or ferric carboxymaltose"],"prefix":"10.1007","volume":"45","author":[{"given":"Nicholas A.","family":"Kennedy","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maureen M.","family":"Achebe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Biggar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes","family":"P\u00f6hlmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9873-7507","authenticated-orcid":false,"given":"Richard F.","family":"Pollock","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,4,3]]},"reference":[{"issue":"5","key":"1548_CR1","doi-asserted-by":"publisher","first-page":"447","DOI":"10.1056\/NEJMoa1810742","volume":"380","author":"IC Macdougall","year":"2019","unstructured":"Macdougall IC, White C, Anker SD, PIVOTAL Investigators and Committees, et al. 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MA has no conflicts of interest to declare. PB declares consultancy fees from Vifor, Fresenius, and Pharmacosmos A\/S. NK declares speaker honoraria, support for meetings and\/or travel, and participation in an advisory board from Pharmacosmos A\/S.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}}]}}