Abstract
Concerns persist about adverse reactions to intravenous (IV) iron. We aimed to determine the relative safety of ferumoxytol compared to other IV iron compounds. This retrospective cohort study with propensity-score matching for patients and drug doses used the Medicare 20% random sample to identify patients (1) without chronic kidney disease (non-CKD) and (2) with non-dialysis-dependent chronic kidney disease (NDD-CKD) who received a first dose of IV iron in 2010±2012. Exposures were ferumoxytol, iron sucrose, sodium ferric gluconate, or iron dextran. Outcomes were hypersensitivity symptoms, anaphylaxis, emergency department (ED) encounters, hospitalizations, and death after acute IV iron exposure. In the primary analysis for reactions on the day of or following exposure, there was no difference in hypersensitivity symptoms (hazard ratio 1.04, 95% confidence interval 0.94±1.16) or hypotension (0.83, 0.52±1.34) between 4289 non-CKD ferumoxytol users and an equal number of users of other compounds; results were similar for 7358 NDD-CKD patients and an equal number of controls. All-cause ED encounters or hospitalizations were less common in both the non-CKD (0.56, 0.45±0.70) and NDD-CKD ferumoxytol-treated patients (0.83, 0.71±0.95). Fewer than 10 deaths occurred in both the non-CKD and NDD-CKD ferumoxytol users and in matched controls; the hazard for death did not differ significantly between ferumoxytol users and controls in the non-CKD patients (2.00, 0.33±11.97) or in the NDD-CKD patients (0.25, 0.04±1.52). Multiple sensitivity analyses showed similar results. Ferumoxytol did not appear to be associated with more adverse reactions than other compounds for the treatment of iron-deficiency anemia in both non-CKD and NDD-CKD patients.
| Original language | English (US) |
|---|---|
| Article number | e0171098 |
| Journal | PloS one |
| Volume | 12 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 2017 |
Bibliographical note
Funding Information:This study was supported by a research contract from AMAG Pharmaceuticals, Waltham, Massachusetts, to the Chronic Disease Research Group, Minneapolis Medical Research Foundation, which employs JBW and DTG and employed EDW and JZ. The contract provides for the Minneapolis Medical Research Foundation authors to have final determination of manuscript content. The funding source had no role in the design of the study, the collection, analysis, or interpretation of the data, or the decision to approve publication of the finished manuscript.
Publisher Copyright:
Copyright © 2017 Wetmore et al.This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
