Absence of potential gadolinium toxicity symptoms following 22,897 gadoteric acid (Dotarem®) examinations, including 3,209 performed on renally insufficient individuals

Laura Young, Shona Matthew, John Houston (Lead / Corresponding author)

Research output: Contribution to journalArticle

Abstract

Objectives: Recent safety concerns regarding gadolinium-based contrast agents (GdCAs) concluded with the suspension of some agents from the European market, yet a clinical consequence remains unknown. We used electronic health records to investigate the incidence of potential toxicity to gadoteric acid (Dotarem®) within our local population, including those with renal insufficiency (RI).
Methods: Data for patients who underwent contrast-enhanced MRI were identified, stratified by renal function at time of scan and retrospectively followed using routinely collected health data. Searches performed were: records of hypersensitivity reactions; diagnoses of nephrogenic systemic fibrosis (NSF); onset of chronic pain, a symptom that has been associated with NSF and the theorised gadolinium deposition disease (GDD); and post-contrast acute kidney injury (PC-AKI). Comparisons were made between patients and controls (those who underwent non-contrast scans) via chi-square and ANOVA statistical tests.
Results: Of the 22,897 contrast-enhanced MRI scans performed locally from 2004–2016 (adult, n = 22,325 and paediatric, n = 572), 14% were performed on patients with RI (30 ≤ eGFR < 60, n = 2,622; 15 ≤ eGFR < 30, n = 464; eGFR < 15, n = 123). Two adult patients (0.01%) suffered hypersensitivity reactions. Zero cases of NSF were reported, with an average follow-up time of 6.0 ± 2.5 years (range, 8 months–15 years). Analysis failed to highlight statistically higher rates of chronic pain onset post-MRI (adult: p = 0.777, paediatric: p = 0.578), or PC-AKI (adult: p = 0.566, paediatric: p = 0.841), in the patient groups compared to controls.
Conclusions: These data indicate that administration of gadoteric acid to RI patients does not result in a higher rate of signs or symptoms that may be associated with gadolinium toxicity when compared to controls.
LanguageEnglish
Number of pages9
JournalEuropean Radiology
Early online date1 Oct 2018
DOIs
Publication statusE-pub ahead of print - 1 Oct 2018

Fingerprint

Gadolinium
Nephrogenic Fibrosing Dermopathy
Acids
Renal Insufficiency
Pediatrics
Acute Kidney Injury
Chronic Pain
Hypersensitivity
Electronic Health Records
Contrast Media
Signs and Symptoms
gadoterate meglumine
Suspensions
Analysis of Variance
Magnetic Resonance Imaging
Kidney
Safety
Incidence
Health
Population

Keywords

  • Contrast media
  • Magnetic resonance imaging
  • Medical record linkage
  • Renal insufficiency

Cite this

@article{adbacf6420fe4193880810eaa37205f3,
title = "Absence of potential gadolinium toxicity symptoms following 22,897 gadoteric acid (Dotarem{\circledR}) examinations, including 3,209 performed on renally insufficient individuals",
abstract = "Objectives: Recent safety concerns regarding gadolinium-based contrast agents (GdCAs) concluded with the suspension of some agents from the European market, yet a clinical consequence remains unknown. We used electronic health records to investigate the incidence of potential toxicity to gadoteric acid (Dotarem{\circledR}) within our local population, including those with renal insufficiency (RI).Methods: Data for patients who underwent contrast-enhanced MRI were identified, stratified by renal function at time of scan and retrospectively followed using routinely collected health data. Searches performed were: records of hypersensitivity reactions; diagnoses of nephrogenic systemic fibrosis (NSF); onset of chronic pain, a symptom that has been associated with NSF and the theorised gadolinium deposition disease (GDD); and post-contrast acute kidney injury (PC-AKI). Comparisons were made between patients and controls (those who underwent non-contrast scans) via chi-square and ANOVA statistical tests.Results: Of the 22,897 contrast-enhanced MRI scans performed locally from 2004–2016 (adult, n = 22,325 and paediatric, n = 572), 14{\%} were performed on patients with RI (30 ≤ eGFR < 60, n = 2,622; 15 ≤ eGFR < 30, n = 464; eGFR < 15, n = 123). Two adult patients (0.01{\%}) suffered hypersensitivity reactions. Zero cases of NSF were reported, with an average follow-up time of 6.0 ± 2.5 years (range, 8 months–15 years). Analysis failed to highlight statistically higher rates of chronic pain onset post-MRI (adult: p = 0.777, paediatric: p = 0.578), or PC-AKI (adult: p = 0.566, paediatric: p = 0.841), in the patient groups compared to controls.Conclusions: These data indicate that administration of gadoteric acid to RI patients does not result in a higher rate of signs or symptoms that may be associated with gadolinium toxicity when compared to controls.",
keywords = "Contrast media, Magnetic resonance imaging, Medical record linkage, Renal insufficiency",
author = "Laura Young and Shona Matthew and John Houston",
note = "This work had received funding from the European Union’s 7th Framework Program for research, technological development and demonstration under grant agreement no. 324487 (ReDVA).",
year = "2018",
month = "10",
day = "1",
doi = "10.1007/s00330-018-5737-z",
language = "English",
journal = "European Radiology",
issn = "0938-7994",
publisher = "Springer Verlag",

}

TY - JOUR

T1 - Absence of potential gadolinium toxicity symptoms following 22,897 gadoteric acid (Dotarem®) examinations, including 3,209 performed on renally insufficient individuals

AU - Young, Laura

AU - Matthew, Shona

AU - Houston, John

N1 - This work had received funding from the European Union’s 7th Framework Program for research, technological development and demonstration under grant agreement no. 324487 (ReDVA).

PY - 2018/10/1

Y1 - 2018/10/1

N2 - Objectives: Recent safety concerns regarding gadolinium-based contrast agents (GdCAs) concluded with the suspension of some agents from the European market, yet a clinical consequence remains unknown. We used electronic health records to investigate the incidence of potential toxicity to gadoteric acid (Dotarem®) within our local population, including those with renal insufficiency (RI).Methods: Data for patients who underwent contrast-enhanced MRI were identified, stratified by renal function at time of scan and retrospectively followed using routinely collected health data. Searches performed were: records of hypersensitivity reactions; diagnoses of nephrogenic systemic fibrosis (NSF); onset of chronic pain, a symptom that has been associated with NSF and the theorised gadolinium deposition disease (GDD); and post-contrast acute kidney injury (PC-AKI). Comparisons were made between patients and controls (those who underwent non-contrast scans) via chi-square and ANOVA statistical tests.Results: Of the 22,897 contrast-enhanced MRI scans performed locally from 2004–2016 (adult, n = 22,325 and paediatric, n = 572), 14% were performed on patients with RI (30 ≤ eGFR < 60, n = 2,622; 15 ≤ eGFR < 30, n = 464; eGFR < 15, n = 123). Two adult patients (0.01%) suffered hypersensitivity reactions. Zero cases of NSF were reported, with an average follow-up time of 6.0 ± 2.5 years (range, 8 months–15 years). Analysis failed to highlight statistically higher rates of chronic pain onset post-MRI (adult: p = 0.777, paediatric: p = 0.578), or PC-AKI (adult: p = 0.566, paediatric: p = 0.841), in the patient groups compared to controls.Conclusions: These data indicate that administration of gadoteric acid to RI patients does not result in a higher rate of signs or symptoms that may be associated with gadolinium toxicity when compared to controls.

AB - Objectives: Recent safety concerns regarding gadolinium-based contrast agents (GdCAs) concluded with the suspension of some agents from the European market, yet a clinical consequence remains unknown. We used electronic health records to investigate the incidence of potential toxicity to gadoteric acid (Dotarem®) within our local population, including those with renal insufficiency (RI).Methods: Data for patients who underwent contrast-enhanced MRI were identified, stratified by renal function at time of scan and retrospectively followed using routinely collected health data. Searches performed were: records of hypersensitivity reactions; diagnoses of nephrogenic systemic fibrosis (NSF); onset of chronic pain, a symptom that has been associated with NSF and the theorised gadolinium deposition disease (GDD); and post-contrast acute kidney injury (PC-AKI). Comparisons were made between patients and controls (those who underwent non-contrast scans) via chi-square and ANOVA statistical tests.Results: Of the 22,897 contrast-enhanced MRI scans performed locally from 2004–2016 (adult, n = 22,325 and paediatric, n = 572), 14% were performed on patients with RI (30 ≤ eGFR < 60, n = 2,622; 15 ≤ eGFR < 30, n = 464; eGFR < 15, n = 123). Two adult patients (0.01%) suffered hypersensitivity reactions. Zero cases of NSF were reported, with an average follow-up time of 6.0 ± 2.5 years (range, 8 months–15 years). Analysis failed to highlight statistically higher rates of chronic pain onset post-MRI (adult: p = 0.777, paediatric: p = 0.578), or PC-AKI (adult: p = 0.566, paediatric: p = 0.841), in the patient groups compared to controls.Conclusions: These data indicate that administration of gadoteric acid to RI patients does not result in a higher rate of signs or symptoms that may be associated with gadolinium toxicity when compared to controls.

KW - Contrast media

KW - Magnetic resonance imaging

KW - Medical record linkage

KW - Renal insufficiency

U2 - 10.1007/s00330-018-5737-z

DO - 10.1007/s00330-018-5737-z

M3 - Article

JO - European Radiology

T2 - European Radiology

JF - European Radiology

SN - 0938-7994

ER -