{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T10:23:20Z","timestamp":1781864600083,"version":"3.54.5"},"reference-count":28,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2020,6,1]],"date-time":"2020-06-01T00:00:00Z","timestamp":1590969600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2020,6]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>Reluctance to use intravenous (IV) iron for the treatment of iron deficiency continues due to a perceived high risk of severe hypersensitivity reactions (HSRs). Additionally, it has been hypothesized that \u2018dextran\u2010derived\u2019 IV iron products (e.g., ferumoxytol [FER] and ferric derisomaltose\/iron isomaltoside 1000 [FDI]) have a higher risk of severe HSRs than \u2018non\u2010dextran\u2010derived\u2019 products (e.g., ferric carboxymaltose [FCM] and iron sucrose [IS]). In the present analysis, HSR data from head\u2010to\u2010head randomized controlled trials (RCTs) with IV iron products were evaluated to determine if differences in safety signals are present among these IV iron formulations.<\/jats:p><\/jats:sec><jats:sec><jats:title>STUDY DESIGN AND METHODS<\/jats:title><jats:p>Reported serious or moderate\u2010to\u2010severe HSR incidence data from five RCTs (FIRM; FERWON\u2010NEPHRO\/\u2010IDA; PHOSPHARE\u2010IDA04\/\u2010IDA05) were used to calculate risk differences with 95% confidence intervals (CIs) for FER, FCM, FDI, and IS. The rates and risk differences for these HSRs were compared.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>The analysis included data for 5247 patients: FER (n = 997), FCM (n = 1117), FDI (n = 2133) and IS (n = 1000). Overall rates of serious or moderate to severe HSRs were low (0.2%\u20101.7%). The risk differences (95% CIs) showed small differences between the IV iron formulations: FER versus FCM, \u22120.1 (\u22120.8 to 0.6); FDI versus IS, 0.1 (\u22120.3 to 0.5); FDI versus FCM, \u22120.9 (\u22123.7 to 1.9).<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p>RCT evidence confirms a low risk of serious or moderate to severe HSRs with newer IV iron formulations and no significant differences among existing commercially available products. Thus, RCT data show that the supposed classification of dextran\u2010derived versus non\u2010dextran\u2010derived IV iron products has no clinical relevance.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.15837","type":"journal-article","created":{"date-parts":[[2020,6,1]],"date-time":"2020-06-01T18:42:42Z","timestamp":1591036962000},"page":"1154-1159","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":30,"title":["Clinical data for intravenous iron \u2013 debunking the hype around hypersensitivity"],"prefix":"10.1111","volume":"60","author":[{"given":"Maureen","family":"Achebe","sequence":"first","affiliation":[{"name":"Brigham and Women's Hospital Dana Farber Cancer Institute, Harvard Medical School  Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas G.","family":"DeLoughery","sequence":"additional","affiliation":[{"name":"Department of Hematology and Medical Oncology, Knight Cancer Center Oregon Health Sciences University  Portland Oregon"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,6]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.0554"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1182\/asheducation-2016.1.57"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejpb.2011.03.016"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2014.111492"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1159\/000451069"},{"key":"e_1_2_8_7_1","first-page":"219","article-title":"Assessment of dextran antigenicity of intravenous iron products by an immunodiffusion assay","volume":"25","author":"Neiser S","year":"2011","journal-title":"Port J Nephrol Hypert"},{"key":"e_1_2_8_8_1","first-page":"311","article-title":"Reply to the letter to the editor by Johannes Ring and Rudi Valenta on the article \u201cAssessment of dextran antigenicity of intravenous iron products by an immunodiffusion assay\u201d","volume":"26","author":"Neiser S","year":"2012","journal-title":"Port J Nephrol Hypert"},{"key":"e_1_2_8_9_1","unstructured":"OCEBMLevels of Evidence Working Group. 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Medical review of Injectafer (VIT\u201045 ferric carboxymaltose injection; FCM) for the treatment of iron deficiency anemia (203565Orig1s000).2013. Available at:https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2013\/203565Orig1s000MedR.pdf."},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2014.10.007"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1080\/17474086.2020.1709437"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.24201"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12773"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2015.10.002"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1097\/WOX.0b013e318211496c"},{"key":"e_1_2_8_26_1","unstructured":"European Medicines Agency. New recommendations to manage risk of allergic reactions with intravenous iron\u2010containing medicines.2013. [cited 2020 Jan 21]. 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