Comment on ‘Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures’

Muckadell, Philip Schaffalitzky de; Strom, Claes Christian

doi:10.1007/s40264-020-00929-0

Cited by 1 publication

(1 citation statement)

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“…Large observational claims database retrospective analyses have suggested these reactions may be more frequent with iron dextran vs newer preparations [4] and with ferumoxytol vs iron sucrose (see Supplementary Table S5 in Wetmore et al [14]), and pharmacovigilance spontaneous reporting database analyses have suggested higher reporting rates with iron dextran, ferumoxytol, and iron isomaltoside than ferric gluconate or ferric carboxymaltose [8,[15][16][17][18]. However, methodological concerns [19][20][21][22][23] and a paucity of longer term data on newer IV iron preparations in many of these publications limit the conclusions that can be reached. Thus, up-to-date analyses are required to further explore signals for potential IV iron-adverse event (AE) associations using established methodologies for analysis of pharmacovigilance spontaneous reporting databases [24,25].…”

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confidence: 99%

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

et al. 2020

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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.

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