What does the boxed warning tell us? Safe practice of using ferumoxytol as an MRI CONTRAST AGENT

C. G. Varallyay, G. B. Toth, Rongwei (Rochelle) Fu, J. P. Netto, J. Firkins, Prakash Ambady, Edward Neuwelt

Research output: Contribution to journalArticle

15 Citations (Scopus)

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. MATERIALSANDMETHODS: 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.

Original languageEnglish (US)
Pages (from-to)1297-1302
Number of pages6
JournalAmerican Journal of Neuroradiology
Volume38
Issue number7
DOIs
StatePublished - Jul 1 2017

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Drug Labeling
Ferrosoferric Oxide
Safety
Research Ethics Committees
Gadolinium
Nausea
Contrast Media
Headache
Diarrhea

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Clinical Neurology

Cite this

What does the boxed warning tell us? Safe practice of using ferumoxytol as an MRI CONTRAST AGENT. / Varallyay, C. G.; Toth, G. B.; Fu, Rongwei (Rochelle); Netto, J. P.; Firkins, J.; Ambady, Prakash; Neuwelt, Edward.

In: American Journal of Neuroradiology, Vol. 38, No. 7, 01.07.2017, p. 1297-1302.

Research output: Contribution to journalArticle

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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. MATERIALSANDMETHODS: 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.",
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