Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products
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ORIGINAL RESEARCH ARTICLE
Frequency and Associated Costs of Anaphylaxis‑ and Hypersensitivity‑Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System Henry Trumbo1 · Karolina Kaluza2 · Syed Numan2 · Lawrence T. Goodnough3 Accepted: 10 November 2020 © The Author(s) 2020
Abstract Introduction and Objective Intravenous iron preparations rapidly correct iron deficiency anemia, with the notable drug class effect of rare, yet potentially life-threatening, administration-related hypersensitivity or anaphylactic reactions. The objective of this comparative study was to assess adverse events associated with four intravenous iron preparations and estimated medical costs, in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods Cases of hypersensitivity reactions and anaphylaxis/anaphylactic shock associated with iron dextran, iron sucrose, ferumoxytol, and ferric carboxymaltose, spontaneously reported to FAERS (1 January, 2014 to 31 December, 2019), were extracted. The reporting odds ratio lower bound 90% confidence interval (ROR05) > 1 and cases ≥ 5 defined a likely signal for a drug–adverse event association. Adverse event-associated medical costs were estimated using Agency for Healthcare Research and Quality/Healthcare Cost and Utilization Project 2016 data. Results For hypersensitivity reactions, ferumoxytol and iron dextran had the highest ROR05 values (5.00 and 4.35, respectively) and greatest proportions of associated deaths (7.1% and 5.3%), followed by iron sucrose (ROR05 3.94, deaths 2.4%), and ferric carboxymaltose (ROR05 3.03, deaths 0.2%). For anaphylaxis/anaphylactic shock, ROR05 for cases/deaths were: 39.32/13.4%, ferumoxytol; 37.80/4.5%, iron dextran; 17.60/4.7%, iron sucrose; and 8.77/no deaths, ferric carboxymaltose. Downstream medical costs per adverse event were highest with iron dextran (US$8615) and ferumoxytol (US$8164), followed by iron sucrose (US$4212), and ferric carboxymaltose (US$1832). Conclusions Reporting rates of hypersensitivity and anaphylaxis with intravenous iron preparations were highest with ferumoxytol and lowest with ferric carboxymaltose in the US FAERS database. Adverse event-related medical costs were highest for iron dextran and ferumoxytol, and lowest for ferric carboxymaltose.
1 Introduction Iron deficiency is the most frequent cause of anemia, which affects 32.9% of the global population [1], and of all nutrient deficiencies, it is the only one that is also commonly Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40264-020-01022-2) contains supplementary material, which is available to authorized users. * Henry Trumbo [email protected] 1
Pharmacy Department, St. Mary Medical Center, 1201 Langhorne‑Newtown Road, Langhorne, PA 19047, USA
2
American Regent, Norristown, PA, USA
3
Stanford University, Stanford, CA, USA
detected in industrialized countries [2]. Both ir
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