Evaluation of the reported rates of hypersensitivity reactions associated with iron dextran and ferric carboxymaltose based on global data from VigiBase™ and IQVIA™ MIDAS® over a ten-year period from 2008 to 2017

References

• GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392:1789–1858.
   PubMed Web of Science ®Google Scholar
• Stevens GA, Finucane MM, De-Regil LM, et al.; Nutrition Impact Model Study Group (Anaemia). Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non-pregnant women for 1995–2011: a systematic analysis of population-representative data. Lancet Glob Health. 2013;1:e16–e25.
   PubMed Web of Science ®Google Scholar
• Kassebaum NJ. GBD 2013 Anemia Collaborators. The global burden of anemia. Hematol Oncol Clin North Am. 2016;30:247–308.
   PubMed Web of Science ®Google Scholar
• Camaschella C. Iron deficiency. Blood. 2019;133:30–39.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Iron deficiency anaemia: assessment, prevention, and control. A guide for programme managers. Geneva: World Health Organization; 2001.
   Google Scholar
• Tolkien Z, Stecher L, Mander AP, et al. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015;10:e0117383.
   PubMed Web of Science ®Google Scholar
• Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016;91:31–38.
   PubMed Web of Science ®Google Scholar
• Peyrin-Biroulet L, Williet N, Cacoub P. Guidelines on the diagnosis and treatment of iron deficiency across indications: a systematic review. Am J Clin Nutr. 2015;102:1585–1594.
   PubMed Web of Science ®Google Scholar
• Auerbach M, Deloughery T. Single-dose intravenous iron for iron deficiency: a new paradigm. Hematology Am Soc Hematol Educ Program. 2016;2016:57–66.
   PubMedGoogle Scholar
• Hedin H, Richter W. Pathomechanisms of dextran-induced anaphylactoid/anaphylactic reactions in man. Int Arch Allergy Appl Immunol. 1982;68:122–126.
   PubMedGoogle Scholar
• Ljungström KG. Pretreatment with dextran 1 makes dextran 40 therapy safer. J Vasc Surg. 2006;43:1070–1072.
   PubMed Web of Science ®Google Scholar
• Neiser S, Wilhelm M, Schwarz K, et al. Assessment of dextran antigenicity of intravenous iron products by an immunodiffusion assay. Port J Nephrol Hypert. 2011;25:219–224.
   Google Scholar
• Bailie GR, Clark JA, Lane CE, et al. Hypersensitivity reactions and deaths associated with intravenous iron preparations. Nephrol Dial Transplant. 2005;20:1443–1449.
   PubMed Web of Science ®Google Scholar
• Szebeni J, Fishbane S, Hedenus M, et al. Hypersensitivity to intravenous iron: classification, terminology, mechanisms and management. Br J Pharmacol. 2015;172:5025–5036.
   PubMed Web of Science ®Google Scholar
• Kreimeier U, Christ F, Kraft D, et al. Anaphylaxis due to hydroxyethyl-starch-reactive antibodies. Lancet. 1995;346:49–50.
   PubMed Web of Science ®Google Scholar
• Injectafer® (ferric carboxymaltose injection). Prescribing information; 2013 [cited 2019 Nov 12]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203565s000lbl.pdf
   Google Scholar
• Center for Drug Evaluation and Research. Medical review of Injectafer (VIT-45, ferric carboxymaltose injection; FCM) for the treatment of iron deficiency anemia (203565Orig1s000); 2013 [cited 2019 Nov 12]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203565Orig1s000MedR.pdf.
   Google Scholar
• Prescrire editors. Fer polymaltose intraveineux: angioedèmes, etc. [Intravenous iron polymaltose: angioedema, etc.]. Rev Prescrire. 2013;31(361):829.
   Google Scholar
• Chenaf C, Pagani M, Parry E, et al. Post-marketing safety profile of ferric carboxymaltose (Ferinject®). Fundam Clin Pharmacol. 2013;27(Suppl 1):101.
   Google Scholar
• Swissmedic. Vigilance News; 2013:11.
   Google Scholar
• Drake S. Precaution for Ferinject® vials. DrugAlert; 2018:404 [cited 2019 Nov 12]. Available from: https://www.hps.com.au/knowledge-centre/drugalert/precaution-for-ferinject-vials/.
   Google Scholar
• Australian Government Department of Health. Therapeutic Goods Administration. Database of adverse event notifications – medicines. Ferinject: Medicine summary; 2018 [cited 2019 Nov 12]. Available from: http://hpscorp.boylentest.com.au/wp-content/uploads/2018/05/20180524_daen-report.pdf.
   Google Scholar
• Wolf M, Koch TA, Bregman DB. Effects of iron deficiency anemia and its treatment on fibroblast growth factor 23 and phosphate homeostasis in women. J Bone Miner Res. 2013;28:1793–1803.
   PubMed Web of Science ®Google Scholar
• Hussain I, Bhoyroo J, Butcher A, et al. Direct comparison of the safety and efficacy of ferric carboxymaltose versus iron dextran in patients with iron deficiency anemia. Anemia. 2013;169107.
   PubMedGoogle Scholar
• Myers B, Myers O, Moore J. Comparative efficacy and safety of intravenous ferric carboxymaltose (Ferinject) and iron(III) hydroxide dextran (Cosmofer) in pregnancy. Obstet Med. 2012;5:105–107.
   PubMedGoogle Scholar
• Théophile H, Laporte JR, Moore N, et al. The case-population study design: an analysis of its application in pharmacovigilance. Drug Saf. 2011;34:861–868.
   PubMed Web of Science ®Google Scholar
• IQVIA™. ACTS 2018. IQVIA quality assurance. 2018 [cited 2019 Nov 12]. Available from: https://www.iqvia.com/-/media/iqvia/pdfs/library/publications/acts-2018-32nd-edition.pdf.
   Google Scholar
• Chertow GM, Mason PD, Vaage-Nilsen O, et al. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant. 2006;21:378–382.
   PubMed Web of Science ®Google Scholar
• Bailie GR, Hörl WH, Verhoef JJ. Differences in spontaneously reported hypersensitivity and serious adverse events for intravenous iron preparations: comparison of Europe and North America. Arzneimittelforschung. 2011;61:267–275.
   PubMed Web of Science ®Google Scholar
• Bailie GR. Comparison of rates of reported adverse events associated with i.v. iron products in the United States. Am J Health Syst Pharm. 2012;69:310–320.
   PubMed Web of Science ®Google Scholar
• Ehlken B, Nathell L, Gohlke A, et al. Evaluation of the reported rates of severe hypersensitivity reactions associated with ferric carboxy-maltose and iron (III) isomaltoside 1000 in Europe based on data from EudraVigilance and VigiBase™ between 2014 and 2017. Drug Saf. 2019;42:463–471.
   PubMed Web of Science ®Google Scholar
• Nathell L, Gohlke A, Wohlfeil S. Reported severe hypersensitivity reactions after intravenous iron administration in the European Economic Area (EEA) before and after implementation of risk minimization measures. Drug Saf. 2020;43:35–43.
   PubMed Web of Science ®Google Scholar
• Uppsala Monitoring Centre. VigiBase: the unique global resource at the heart of the drive for safer use of medicines [cited 2019 Nov 12]. Available from: https://www.who-umc.org/vigibase/vigibase/.
   Google Scholar
• Medical Dictionary for Regulatory Activities (MedDRA®). Standardised MedDRA Queries [cited 2019 Nov 12]. Available from: https://www.meddra.org/standardised-meddra-queries.
   Google Scholar
• Mulder MB, van den Hoek HL, Birnie E, et al. Comparison of hypersensitivity reactions of intravenous iron: iron isomaltoside-1000 (Monofer®) versus ferric carboxy-maltose (Ferinject®). A single center, cohort study. Br J Clin Pharmacol. 2019;85:385–392.
   PubMed Web of Science ®Google Scholar
• Weber JCP. Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs. In: Rainsford KD, Velo GD, editors. Side-effects of anti-inflammatory drugs, advances in inflammation research. New York: Raven Press; 1984. p. 1–7.
   Google Scholar
• Schaffalitzky de Muckadell P, Strom CC. Comment on ‘Evaluation of the reported rates of severe hypersensitivity reactions associated with ferric carboxy-maltose and iron (III) isomaltoside 1000 in Europe based on data from EudraVigilance and VigiBase™ between 2014 and 2017ʹ. Drug Saf. 2019;42:689–691.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Assessment report for: Iron containing intravenous (IV) medicinal products (EMA/549569/2013); 2013 [cited 2019 Nov 12]. Available from: https://www.ema.europa.eu/en/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-assessment-report_en.pdf.
   Google Scholar
• Uppsala Monitoring Centre. Caveat document. Statement of reservations, limitations and conditions relating to data released from VigiBase, the WHO global database of individual case safety reports (ICSRs). 2018 [cited 2019 Nov 12]. Available from: https://www.who-umc.org/media/164610/umc_caveat.pdf.
   Google Scholar
• European Medicines Agency. Rapid response to BMJ. Re: Pandemrix vaccine: why was the public not told of early warning signs? (EMA/659264/2018). 2018 [cited 2019 Nov 12]. Available from: https://www.ema.europa.eu/en/documents/other/european-medicines-agency-rapid-response-british-medical-journal-pandemrix_.pdf.
   Google Scholar
• Wysowski DK, Swartz L, Borders-Hemphill BV, et al. Use of parenteral iron products and serious anaphylactic-type reactions. Am J Hematol. 2010;85:650–654.
   PubMed Web of Science ®Google Scholar
• Wang C, Graham DJ, Kane RC, et al. Comparative risk of anaphylactic reactions associated with intravenous iron products. JAMA. 2015;314:2062–2068.
   PubMed Web of Science ®Google Scholar
• Therapeutics Initiative. Intravenous (IV) iron for severe iron deficiency. Vancouver, British Columbia, Canada: Therapeutics Letter; 2015. p. 97.
   Google Scholar
• DeLoughery TG, Auerbach M. Is low-molecular weight iron dextran really the most risky iron? Unconvincing data from an unconvincing study. Am J Hematol. 2016;91:451–452.
   PubMed Web of Science ®Google Scholar
• Rampton D, Folkersen J, Fishbane S, et al. Hypersensitivity reactions to intravenous iron: guidance for risk minimization and management. Haematologica. 2014;99:1671–1676.
   PubMed Web of Science ®Google Scholar
• Cochrane Consumer Network. Levels of evidence [cited 2019 Nov 12]. Available from: https://consumers.cochrane.org/levels-evidence.
   Google Scholar
• European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions (EMA/209012/2015); 2017 [cited 2019 Nov 12]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-ix-addendum-i-methodological-aspects-signal_en.pdf.
   Google Scholar
• Aksan A, Işık H, Radeke HH, et al. Systematic review with network meta-analysis: comparative efficacy and tolerability of different intravenous iron formulations for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2017;45:1303–1318.
   PubMed Web of Science ®Google Scholar
• Adkinson NF, Strauss WE, Macdougall IC, et al. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: a randomized trial. Am J Hematol. 2018;93:683–690.
   PubMed Web of Science ®Google Scholar
• Auerbach M, Henry D, Derman RJ, et al. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial. Am J Hematol. 2019;94:1007–1014.
   PubMed Web of Science ®Google Scholar
• Bhandari S, Kalra PA, Berkowitz M, et al. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial. Nephrol Dial Transplant. 2020. DOI:10.1093/ndt/gfaa011.
   PubMed Web of Science ®Google Scholar