Comparative risk of anaphylactic reactions associated With intravenous iron products
Open accessAbstract
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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A number of recent studies have concluded that the frequency of hypersensitivity reactions is higher with dextran-based intravenous iron preparations (not only with the old high molecular weight compounds) than with non-dextran containing products.
“Nevertheless, it is intriguing that a number of recent studies have come to the conclusion that the frequency of hypersensitivity reactions is higher with dextran-based intravenous iron preparations (not only with the old high molecular weight compounds) than with non-dextran containing products [9,10,11,12].”
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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
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2015-11-17
- Volume
- 314
- Issue
- 19
- Pages
- 2062
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- 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 › 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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