Adverse allergic reactions to linear ionic gadolinium-based contrast agents: experience with 194, 400 injections

Clin Radiol. 2015 May;70(5):466-75. doi: 10.1016/j.crad.2014.12.011. Epub 2015 Jan 24.

Abstract

Aim: To report the authors' experience with the administration of four gadolinium-based contrast agents (GBCA; gadopentetate dimeglumine, gadofosveset trisodium, gadoxetate disodium and gadobenate dimeglumine) in a large study population at a single, large academic medical centre.

Materials and methods: The institutional review board approved this retrospective study in which data in the electronic incident reporting system were searched. A total of 194, 400 intravenous administrations of linear ionic GBCAs were assessed for the incidence of adverse reactions and risk factors from 1 January 2007 to 14 January 2014. The severity of reactions (mild, moderate, and severe), patient type (outpatients, inpatients, and emergency), examination type, and treatment options were also investigated.

Results: In total, 204/194400 (0.1%) patients (mean age 45.7 ± 14.9) showed adverse reactions, consisting of 6/746 (0.80%), 10/3200 (0.31%), 14/6236 (0.22%) and 174/184218 (0.09%), for gadofosveset trisodium, gadoxetate disodium, gadobenate dimeglumine, and gadopentetate dimeglumine, respectively. An overall significant difference was found between different GBCAs regarding the total number of reactions (p < 0.0001). When comparing the GBCAs together, significant differences were found between gadofosveset trisodium versus gadopentetate dimeglumine (p < 0.0001), gadofosveset trisodium versus gadobenate dimeglumine (p = 0.0051), gadoxetate disodium versus gadopentetate dimeglumine (p < 0.0001) and gadopentetate dimeglumine versus gadobenate dimeglumine (p = 0.0013). Rate of reaction was higher in females (F: 146/113187, 0.13%/M: 58/81213, 0.07%; p < 0.0001). Rate of reactions was higher in outpatient (180/158885, 0.11%), emergency (10/10413, 0.10%), and inpatients (14/25102, 0.05%), respectively (p < 0.0001). Most of the patients had mild symptoms 171/204 (83.8%). Abdomen-pelvis, liver, and thoracic examinations had highest rates of reactions (0.17 versus 0.16 versus 0.15).

Conclusion: The overall rate of adverse reaction to GBCAs was 0.1%. The rates of reactions were highest in gadofosveset trisodium with (0.80%), followed by gadoxetate disodium (0.31%), gadobenate dimeglumine (0.22%) and gadopentetate dimeglumine (0.09%).

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Contrast Media / adverse effects*
  • Drug Hypersensitivity*
  • Female
  • Gadolinium / adverse effects*
  • Gadolinium DTPA / adverse effects*
  • Humans
  • Injections
  • Male
  • Meglumine / adverse effects
  • Meglumine / analogs & derivatives*
  • Middle Aged
  • Organometallic Compounds / adverse effects*
  • Retrospective Studies
  • Risk Factors
  • Severity of Illness Index
  • Sex Factors

Substances

  • Contrast Media
  • Organometallic Compounds
  • gadolinium ethoxybenzyl DTPA
  • gadobenic acid
  • Meglumine
  • Gadolinium
  • Gadolinium DTPA
  • gadofosveset trisodium