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Assessment of adverse reaction rates during gadoteridol-enhanced MR imaging in 28,078 patients

Desiree E Morgan1, J Stephen Spann, Mark E Lockhart

  • 1Department of Radiology, University of Alabama at Birmingham, 619 19th St S, JT N322, Birmingham, AL 35233, USA. dmorgan@uabmc.edu

Radiology
|January 21, 2011
PubMed
Abstract

Insights

Adverse reaction rates for gadoteridol MRI contrast were low, with nausea being the most common issue. This macrocyclic agent

Area of Science:

  • Radiology
  • Pharmacovigilance
  • Medical Imaging

Background:

  • Gadolinium-based contrast agents (GBCAs) are essential for magnetic resonance (MR) imaging.
  • Gadoteridol is a macrocyclic GBCA used institutionally.
  • Monitoring adverse reactions is crucial for patient safety.

Purpose of the Study:

  • To determine the adverse reaction rates associated with gadoteridol.
  • Evaluate reactions in a large patient cohort undergoing routine MR imaging.
  • Compare observed rates with previously reported data.

Main Methods:

  • Prospective observational study of 28,078 patients receiving intravenous gadoteridol.
  • Adverse reactions were documented by technologists and classified by severity.
  • Statistical analysis using Fisher exact and chi-squared tests.

Main Results:

  • Overall adverse reaction rate was 0.666% (187 patients).
  • Nausea/vomiting was the most frequent reaction (0.530% of all patients).
  • Injection method and dose did not significantly impact reaction rates or severity.

Conclusions:

  • The observed adverse reaction rate for gadoteridol was lower than previously reported.
  • Nausea rates were significantly lower than those in clinical trials leading to FDA approval.
  • Gadoteridol exhibits comparable safety to linear gadolinium-based contrast agents.

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