Cited by 219Drug-Induced Adverse ReactionsFood Allergy and Anaphylaxis ResearchPharmacovigilance and Adverse Drug Reactions

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Comparative Risk of Anaphylactic Reactions Associated With Intravenous Iron Products

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Wang, Cunlin, Graham, David J., Kane, Robert C., Xie, Diqiong, Wernecke, Michael, Levenson, Mark, MaCurdy, Thomas E., Houstoun, Monica, Ryan, Qin, Wong, Sarah, Mott, Katrina, Sheu, Ting-Chang, Limb, Susan, Worrall, Chris, Kelman, Jeffrey A., Reichman, Marsha E.·2015·JAMA

DOI 10.1001/jama.2015.15572

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Abstract

IMPORTANCE: All intravenous (IV) iron products are associated with anaphylaxis, but the comparative safety of each product has not been well established. OBJECTIVE: To compare the risk of anaphylaxis among marketed IV iron products. DESIGN, SETTING, AND PARTICIPANTS: Retrospective new user cohort study of IV iron recipients (n = 688,183) enrolled in the US fee-for-service Medicare program from January 2003 to December 2013. Analyses involving ferumoxytol were limited to the period January 2010 to December 2013. EXPOSURES: Administrations of IV iron dextran, gluconate, sucrose, or ferumoxytol as reported in outpatient Medicare claims data. MAIN OUTCOMES AND MEASURES: Anaphylaxis was identified using a prespecified and validated algorithm defined with standard diagnosis and procedure codes and applied to both inpatient and outpatient Medicare claims. The absolute and relative risks of anaphylaxis were estimated, adjusting for imbalances among treatment groups. RESULTS: A total of 274 anaphylaxis cases were identified at first exposure, with an additional 170 incident anaphylaxis cases identified during subsequent IV iron administrations. The risk for anaphylaxis at first exposure was 68 per 100,000 persons for iron dextran (95% CI, 57.8-78.7 per 100,000) and 24 per 100,000 persons for all nondextran IV iron products combined (iron sucrose, gluconate, and ferumoxytol) (95% CI, 20.0-29.5 per 100,000) , with an adjusted odds ratio (OR) of 2.6 (95% CI, 2.0-3.3; P < .001). At first exposure, when compared with iron sucrose, the adjusted OR of anaphylaxis for iron dextran was 3.6 (95% CI, 2.4-5.4); for iron gluconate, 2.0 (95% CI 1.2, 3.5); and for ferumoxytol, 2.2 (95% CI, 1.1-4.3). The estimated cumulative anaphylaxis risk following total iron repletion of 1000 mg administered within a 12-week period was highest with iron dextran (82 per 100,000 persons, 95% CI, 70.5- 93.1) and lowest with iron sucrose (21 per 100,000 persons, 95% CI, 15.3- 26.4). CONCLUSIONS AND RELEVANCE: Among patients in the US Medicare nondialysis population with first exposure to IV iron, the risk of anaphylaxis was highest for iron dextran and lowest for iron sucrose.

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Authors: Wang, C., Graham, D. J., Kane, R. C., Xie, D., Wernecke, M., Levenson, M., MaCurdy, T. E., Houstoun, M., Ryan, Q., Wong, S., Mott, K., Sheu, T.-C., Limb, S., Worrall, C., Kelman, J. A., & Reichman, M. E.
Affiliations: United States Food and Drug Administration (US)
Acumen (United States) (US)
Centers for Medicare and Medicaid Services (US)
Corresponding author: Wang, Cunlin
ORCID: Graham, David J.
Wernecke, Michael
Levenson, Mark
MaCurdy, Thomas E.
Mott, Katrina
Sheu, Ting-Chang
Reichman, Marsha E.
Venue: JAMA
Publisher: American Medical Association (AMA)
Published: 2015-11-17
Volume: 314
Issue: 19
Pages: 2062
ISSN: 0002-9955 (ISSN-L)
0098-7484
DOI: 10.1001/jama.2015.15572
OpenAlex: W2179358297
Cited by: 219
References: 28
Citations by year: 2026: 10 · 2025: 13 · 2024: 14 · 2023: 14 · 2022: 32 · 2021: 20 · 2020: 27 · 2019: 21 · 2018: 20 · 2017: 20 · 2016: 27 · 2015: 1
FWCI: 16.33
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: JAMA (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Pharmacology (medical) › Drug-Induced Adverse Reactions
Health Sciences › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords: anaphylaxis, intravenous iron, iron dextran, iron sucrose, iron gluconate, ferumoxytol, drug safety, adverse drug reactions, iron deficiency anemia, Medicare beneficiaries, iron repletion
MeSH terms: Ferric Oxide, Saccharated, Aged, Anaphylaxis, Female, Ferric Compounds, Glucaric Acid, Gluconates, Humans, Injections, Intravenous, Iron-Dextran Complex, Male, Retrospective Studies, Risk, United States, Incidence, Medicare Part A, Ferrosoferric Oxide

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Comparative Risk of Anaphylactic Reactions Associated With Intravenous Iron Products

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