Costs of IV iron-related anaphylaxis and hypersensitivity
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Costs of IV iron-related anaphylaxis and hypersensitivity Rates and costs of anaphylaxis and drug hypersensitivity differ between IV iron products in the US, and are lowest with ferric carboxymaltose, according to findings of an American Regent-funded study published in Drug Safety. Data from the US FDA Adverse Event Reporting System (FAERS) database (2014–2019) were used to investigate reporting odds ratios based on the lower bounds of the 90% CI (ROR05) for anaphylaxis and hypersensitivity associated with iron dextran, iron sucrose, ferumoxytol and ferric carboxymaltose [American Regent]. Data from the Agency for Healthcare Research and Quality/Healthcare Cost and Utilization Project (2016) were used to estimate adverse event (AE)-related medical costs. ROR05 values for hypersensitivity, and the associated death rate, were greater for ferumoxytol (ROR05 5.00; deaths 7.1%) and iron dextran (4.35; 5.3%) than for iron sucrose (3.94; 2.4%) and ferric carboxymaltose (3.03; 0.2%). ROR05 values for analylaxis were also greater for ferumoxytol (39.32; 13.4%), iron dextran (37.80; 4.5%) and iron sucrose (17.60; 4.7%) than for ferric carboxymaltose (8.77; 0 deaths). AE-related medical costs were $8615* with iron dextran, $8164 with ferumoxytol, $4212 with iron sucrose and $1832 with ferric carboxymaltose. "We found that although all the IV iron formulations we considered had signals for likely drug–AE associations based on ROR05 for hypersensitivity reactions and anaphylaxis, signals were highest for ferumoxytol and iron dextran, intermediate for iron sucrose, and lowest for ferric carboxymaltose . . . Downstream direct medical costs based on these AEs supported these findings," concluded the authors. * 2019 US dollars Trumbo H, et al. 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. Drug Safety : 25 Nov 2020. Available from: URL: https://doi.org/10.1007/ 803519786 s40264-020-01022-2
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Reactions 5 Dec 2020 No. 1833
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