Skip to main content
Advertisement

Main menu

  • Home
  • Content
    • Current Issue
    • Publication Preview--Ahead of Print
    • Past Issue Archive
    • Case of the Week Archive
    • Classic Case Archive
    • Case of the Month Archive
  • For Authors
  • About Us
    • About AJNR
    • Editors
    • American Society of Neuroradiology
  • Submit a Manuscript
  • Podcasts
    • Subscribe on iTunes
    • Subscribe on Stitcher
  • More
    • Subscribers
    • Permissions
    • Advertisers
    • Alerts
    • Feedback
  • Other Publications
    • ajnr

User menu

  • Subscribe
  • Alerts
  • Log in

Search

  • Advanced search
American Journal of Neuroradiology
American Journal of Neuroradiology

American Journal of Neuroradiology

  • Subscribe
  • Alerts
  • Log in

Advanced Search

  • Home
  • Content
    • Current Issue
    • Publication Preview--Ahead of Print
    • Past Issue Archive
    • Case of the Week Archive
    • Classic Case Archive
    • Case of the Month Archive
  • For Authors
  • About Us
    • About AJNR
    • Editors
    • American Society of Neuroradiology
  • Submit a Manuscript
  • Podcasts
    • Subscribe on iTunes
    • Subscribe on Stitcher
  • More
    • Subscribers
    • Permissions
    • Advertisers
    • Alerts
    • Feedback
  • Follow AJNR on Twitter
  • Visit AJNR on Facebook
  • Follow AJNR on Instagram
  • Join AJNR on LinkedIn
  • RSS Feeds
Research ArticlePATIENT SAFETY
Open Access

What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent

C.G. Varallyay, G.B. Toth, R. Fu, J.P. Netto, J. Firkins, P. Ambady and E.A. Neuwelt
American Journal of Neuroradiology May 2017, DOI: https://doi.org/10.3174/ajnr.A5188
C.G. Varallyay
From the Departments of Radiology (C.G.V., J.P.N.), Neurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.), Medical Informatics and Clinical Epidemiology (R.F.), and Neurosurgery (E.A.N.) and School of Public Health (R.F.), Oregon Health & Science University, Portland, Oregon; and Portland Veterans Affairs Medical Center (E.A.N.), Portland, Oregon.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for C.G. Varallyay
G.B. Toth
From the Departments of Radiology (C.G.V., J.P.N.), Neurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.), Medical Informatics and Clinical Epidemiology (R.F.), and Neurosurgery (E.A.N.) and School of Public Health (R.F.), Oregon Health & Science University, Portland, Oregon; and Portland Veterans Affairs Medical Center (E.A.N.), Portland, Oregon.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for G.B. Toth
R. Fu
From the Departments of Radiology (C.G.V., J.P.N.), Neurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.), Medical Informatics and Clinical Epidemiology (R.F.), and Neurosurgery (E.A.N.) and School of Public Health (R.F.), Oregon Health & Science University, Portland, Oregon; and Portland Veterans Affairs Medical Center (E.A.N.), Portland, Oregon.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for R. Fu
J.P. Netto
From the Departments of Radiology (C.G.V., J.P.N.), Neurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.), Medical Informatics and Clinical Epidemiology (R.F.), and Neurosurgery (E.A.N.) and School of Public Health (R.F.), Oregon Health & Science University, Portland, Oregon; and Portland Veterans Affairs Medical Center (E.A.N.), Portland, Oregon.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for J.P. Netto
J. Firkins
From the Departments of Radiology (C.G.V., J.P.N.), Neurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.), Medical Informatics and Clinical Epidemiology (R.F.), and Neurosurgery (E.A.N.) and School of Public Health (R.F.), Oregon Health & Science University, Portland, Oregon; and Portland Veterans Affairs Medical Center (E.A.N.), Portland, Oregon.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for J. Firkins
P. Ambady
From the Departments of Radiology (C.G.V., J.P.N.), Neurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.), Medical Informatics and Clinical Epidemiology (R.F.), and Neurosurgery (E.A.N.) and School of Public Health (R.F.), Oregon Health & Science University, Portland, Oregon; and Portland Veterans Affairs Medical Center (E.A.N.), Portland, Oregon.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for P. Ambady
E.A. Neuwelt
From the Departments of Radiology (C.G.V., J.P.N.), Neurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.), Medical Informatics and Clinical Epidemiology (R.F.), and Neurosurgery (E.A.N.) and School of Public Health (R.F.), Oregon Health & Science University, Portland, Oregon; and Portland Veterans Affairs Medical Center (E.A.N.), Portland, Oregon.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for E.A. Neuwelt
  • Article
  • Supplemental
  • Info & Metrics
  • PDF
Loading

Abstract

BACKGROUND AND PURPOSE: Despite the label change and the FDA's boxed warning added to the Feraheme (ferumoxytol) label in March 2015, radiologists have shown increasing interest in using ferumoxytol as an MR imaging contrast agent as a supplement or alternative to gadolinium. The goals of this study were to provide information regarding ferumoxytol safety as an imaging agent in a single center and to assess how the Feraheme label change may affect this potential, currently off-label indication.

MATERIALS AND METHODS: This retrospective study evaluated the overall frequency of ferumoxytol-related adverse events when used for CNS MR imaging. Patients with various CNS pathologies were enrolled in institutional review board–approved imaging studies. Ferumoxytol was administered as multiple rapid bolus injections. The risk of adverse events was correlated with demographic data/medical history.

RESULTS: The safety of 671 ferumoxytol-enhanced MR studies in 331 patients was analyzed. No anaphylactic, life-threatening, or fatal (grade 4 or 5) adverse events were recorded. The overall proportion of ferumoxytol-related grade 1–3 adverse events was 10.6% (8.6% occurring within 48 hours), including hypertension (2.38%), nausea (1.64%), diarrhea (1.04%), and headache (1.04%). History of 1 or 2 allergies was associated with an increased risk of adverse events (14.61% versus 7.51% [no history]; P = .007).

CONCLUSIONS: The frequency of mild ferumoxytol-related adverse events was comparable with literature results, and no serious adverse event was recorded. Although the recommendations in the boxed warning should be followed, serious adverse events appear to be rare, and with proper precautions, ferumoxytol may be a valuable MR imaging agent.

Abbreviations

AE
adverse event
CTCAE
Common Terminology Criteria for Adverse Events
HSR
hypersensitivity reaction
  • © 2017 American Society of Neuroradiology

Indicates open access to non-subscribers at www.ajnr.org

Next
Back to top
Advertisement
Download PDF
Email Article

Thank you for your interest in spreading the word on American Journal of Neuroradiology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent
(Your Name) has sent you a message from American Journal of Neuroradiology
(Your Name) thought you would like to see the American Journal of Neuroradiology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent
C.G. Varallyay, G.B. Toth, R. Fu, J.P. Netto, J. Firkins, P. Ambady, E.A. Neuwelt
American Journal of Neuroradiology May 2017, DOI: 10.3174/ajnr.A5188

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent
C.G. Varallyay, G.B. Toth, R. Fu, J.P. Netto, J. Firkins, P. Ambady, E.A. Neuwelt
American Journal of Neuroradiology May 2017, DOI: 10.3174/ajnr.A5188
del.icio.us logo Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One
Purchase

Jump to section

  • Article
  • Supplemental
  • Info & Metrics
  • PDF

Related Articles

  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Crossref
  • Google Scholar

This article has not yet been cited by articles in journals that are participating in Crossref Cited-by Linking.

More in this TOC Section

PATIENT SAFETY

  • Impact of Kidney Function on CNS Gadolinium Deposition in Patients Receiving Repeated Doses of Gadobutrol
  • Contrast-Induced Acute Kidney Injury in Radiologic Management of Acute Ischemic Stroke in the Emergency Setting
  • Nephrogenic Systemic Fibrosis Risk Assessment and Skin Biopsy Quantification in Patients with Renal Disease following Gadobenate Contrast Administration
Show more PATIENT SAFETY

ADULT BRAIN

  • 3D Enhancement Color Maps in the Characterization of Intracranial Atherosclerotic Plaques
  • Detection of Early Ischemic Changes with Virtual Noncontrast Dual-Energy CT in Acute Ischemic Stroke: A Noninferiority Analysis
  • Neuroimaging Findings in CHANTER Syndrome: A Case Series
Show more ADULT BRAIN

Similar Articles

Advertisement

News and Updates

  • Lucien Levy Best Research Article Award
  • Thanks to our 2021 Distinguished Reviewers
  • Press Releases

Resources

  • Evidence-Based Medicine Level Guide
  • How to Participate in a Tweet Chat
  • AJNR Podcast Archive
  • Ideas for Publicizing Your Research
  • Librarian Resources
  • Terms and Conditions

Opportunities

  • Share Your Art in Perspectives
  • Get Peer Review Credit from Publons
  • Moderate a Tweet Chat

American Society of Neuroradiology

  • Neurographics
  • ASNR Annual Meeting
  • Fellowship Portal
  • Position Statements

© 2022 by the American Society of Neuroradiology | Print ISSN: 0195-6108 Online ISSN: 1936-959X

Powered by HighWire