MRI with ferumoxytol: A single center experience of safety across the age spectrum

J Magn Reson Imaging. 2017 Mar;45(3):804-812. doi: 10.1002/jmri.25412. Epub 2016 Aug 2.

Abstract

Purpose: To summarize our single-center safety experience with the off-label use of ferumoxytol for magnetic resonance imaging (MRI) and to compare the effects of ferumoxytol on monitored physiologic indices in patients under anesthesia with those of gadofosveset trisodium.

Materials and methods: Consecutive patients who underwent ferumoxytol-enhanced (FE) MRI exams were included. Adverse events (AEs) were classified according to the Common Terminology Criteria for Adverse Events v4.0. In a subgroup of patients examined under general anesthesia, recording of blood pressure, heart rate, oxygen saturation, and end-tidal CO2 was performed. A comparable group of 23 patients who underwent gadofosveset-enhanced (GE) MRI under anesthesia with similar monitoring was also analyzed.

Results: In all, 217 unique patients, ages 3 days to 94 years, underwent FE-MRI. No ferumoxytol-related severe, life-threatening, or fatal AEs occurred acutely or at follow-up. Two patients developed ferumoxytol-related nausea. Between-group (FE- vs. GE-MRI) comparisons showed no statistical difference in heart rate (P = 0.69, 95% confidence interval [CI] 96-113 bpm), mean arterial blood pressure (MAP) (P = 0.74, 95% CI 44-52 mmHg), oxygen saturation (P = 0.76, 95% CI 94-98%), and end-tidal CO2 (P = 0.73, 95% CI 31-37 mmHg). No significant change in MAP (P = 0.12, 95% CI 50-58 mmHg) or heart rate (P = 0.25, 95% CI 91-105 bpm) was noted between slow infusion of ferumoxytol (n = 113) vs. bolus injection (n = 104).

Conclusion: In our single-center experience, no serious AEs occurred with the diagnostic use of ferumoxytol across a wide spectrum of age, renal function, and indications. Because of the limited sample size, firm conclusions cannot be drawn about the generalizability of our results. Thus, vigilance and monitoring are recommended to mitigate potential rare adverse reactions.

Level of evidence: 2 J. Magn. Reson. Imaging 2017;45:804-812.

Keywords: USPIO; contrast agent; ferumoxytol; magnetic resonance angiography; magnetic resonance imaging.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • Age Distribution
  • Aged
  • Aged, 80 and over
  • Child
  • Child, Preschool
  • Contrast Media*
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Female
  • Ferrosoferric Oxide*
  • Humans
  • Infant
  • Infant, Newborn
  • Los Angeles / epidemiology
  • Magnetic Resonance Imaging / statistics & numerical data*
  • Male
  • Middle Aged
  • Off-Label Use / statistics & numerical data*
  • Patient Safety
  • Retrospective Studies
  • Risk Factors
  • Young Adult

Substances

  • Contrast Media
  • Ferrosoferric Oxide