190
Views
0
CrossRef citations to date
0
Altmetric
Original Research

Data mining and analysis of the adverse events derived signals of 4 gadolinium-based contrast agents based on the US Food and drug administration adverse event reporting system

ORCID Icon, ORCID Icon & ORCID Icon
Pages 339-352 | Received 12 Aug 2023, Accepted 13 Oct 2023, Published online: 24 Oct 2023

References

  • Runge VM. Commentary on T1-weighted hypersignal in the deep cerebellar nuclei after repeated administrations of gadolinium-based contrast agents in healthy rats: difference between linear and macrocyclic agents. Invest Radiol. 2015;50:481–482. doi: 10.1097/RLI.0000000000000182
  • Li H, Sun J, Zhu H, et al. Recent advances in development of dendritic polymer-based nanomedicines for cancer diagnosis. Wiley interdisciplinary reviews. Nanomed Nanobiotechnol. 2021;13(2):e1670. doi: 10.1002/wnan.1670
  • Idée JM, Port M, Robic C, et al. Role of thermodynamic and kinetic parameters in gadolinium chelate stability. J Magn Reson Imaging. 2009;30(6):1249–1258. doi: 10.1002/jmri.21967
  • Nakamura R, Takanezawa Y, Ohshiro Y, et al. Effects of chemical forms of gadolinium on the spleen in mice after single intravenous administration. Biochem Biophys Rep. 2022;29:101217. doi: 10.1016/j.bbrep.2022.101217
  • Li A, Wong CS, Wong MK, et al. Acute adverse reactions to magnetic resonance contrast media–gadolinium chelates. Br J Radiol. 2006;79:368–371. doi: 10.1259/bjr/88469693
  • Jordan RM, Mintz RD. Fatal reaction to gadopentetatedime glumine. ALR. 1995;164(3):743–744. doi: 10.2214/ajr.164.3.7863905
  • Aran S, Shaqdan KW, Abujudeh HH. Adverse allergic reactions to linear Ionic gadolinium-based contrast agents: experience with 194, 400 injections. Clin Radiol. 2015;70:466–475. doi: 10.1016/j.crad.2014.12.011
  • Kanda T, Ishii K, Kawaguchi H, et al. High signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images: relationship with increasing cumulative dose of a gadolinium-based contrast material. Radiology. 2014;270(3):834–841. doi: 10.1148/radiol.13131669
  • Adin ME, Kleinberq L, Vaidya D, et al. Hyperintense dentate nuclei on T1-weighted MRI: relation to repeat gadolinium administration. AJNR Am J Neuroradiol. 2015;36(10):1859–1865. doi: 10.3174/ajnr.A4378
  • Luo K, Liu G, Zhang X, et al. Functional L-Lysine dendritic macromolecules as liver-imaging probes. Macromol biosci. 2009;9(12):1227–1236. doi: 10.1002/mabi.200900231
  • Schieda NB, van der Pol C, Walker D, et al. Adverse events to the gadolinium-based contrast agent Gadoxetic Acid: systematic review and meta-analysis. Radiology. 2020;297(3):565–572. doi: 10.1148/radiol.2020200073
  • Hope TA, Herfkens RJ, Denianke KS, et al. Nephrogenic systemic fibrosis in patients with chronic kidney disease who received Gadopentetate Dimeglumine. Invest Radiol. 2009;44(3):135–139. doi: 10.1097/RLI.0b013e31819343ba
  • Cowper SE, Robin HS, Steinberg SM, et al. Scleromyxoedema like cutaneous diseases in renal-dialysis patients. Lancet. 2000;356(9234):1000–1001. doi: 10.1016/S0140-6736(00)02694-5
  • Grobner T. Gadolinium – a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant. 2006;21(4):1104–1108. doi: 10.1093/ndt/gfk062
  • Idee JM, Port M, Raynal I, et al. Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review. Fundam Clin Pharmacol. 2006;20:563–576. doi: 10.1111/j.1472-8206.2006.00447.x
  • Dewachter P, Laroche D, Mouton-Faivre C, et al. Immediate reactions following iodinated contrast media injection: a study of 38 cases. Eur J Radiol. 2011;77:495–501. doi: 10.1016/j.ejrad.2009.09.019
  • Davenport MS, Dillman JR, Cohan RH, et al. Effect of abrupt substitution of gadobenate dimeglumine for gadopentetate dimeglumine on rate of allergic-like reactions. Radiology. 2013;266(3):773–782. doi: 10.1148/radiol.12120253
  • Zou Z, Zhang HL, Roditi GH, et al. Nephrogenic systemic fibrosis: review of 370 biopsyconfirmed cases. JACC Cardiovascal Imaging. 2011;4(11):1206–1216. doi: 10.1016/j.jcmg.2011.08.013
  • Zhou J, Wei Z, Xu B, et al. Pharmacovigilance of triazole antifungal agents: analysis of the FDA adverse event reporting system (FAERS) database. Front Pharmacol. 2022;15:1039867. doi: 10.3389/fphar.2022.1039867
  • Shahid I, Joseph A, Lancelot E. Use of real-life safety data from international pharmacovigilance databases to assess the importance of symptoms associated with gadolinium exposure. Invest Radiol. 2022;57(10):664–673. doi: 10.1097/RLI.0000000000000880
  • Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10:483–486. doi: 10.1002/pds.677
  • Hauben M, Zhou X. Quantitative methods in pharmacovigilance: focus on signal detection. Drug Saf: Int J Medi Toxicol Drug Exper. 2003;26(3):159–186. doi: 10.2165/00002018-200326030-00003
  • Chai S, Zhan JL, Zhao LM, et al. Safety of triazole antifungals: a pharmacovigilance study from 2004 to 2021 based on FAERS. Ther Adv Drug Saf. 2022;13:1–13. doi: 10.1177/20420986221143266
  • Semelka RC, Prybylski JP, Ramalho M. Influence of excess ligand on nephrogenic systemic fibrosis associated with nonionic, linear gadolinium-based contrast agents. Magn Reson Imaging. 2019;58:174–178. doi: 10.1016/j.mri.2018.11.015
  • Moreno-Romero JA, Segura S, Mascaró JM Jr, et al. Nephrogenic systemic fibrosis: a case series suggesting gadolinium as a possible aetiological factor. Br J Dermatol. 2007;157(4):783–787. doi: 10.1111/j.1365-2133.2007.08067.x
  • Todd DJ, Kay J. Gadolinium-induced fibrosis. Annu Rev Med. 2016;67:273–291. doi: 10.1146/annurev-med-063014-124936
  • Wagner B, Drel V, Gorin Y. Pathophysiology of gadolinium-associated systemic fibrosis. Am J Physiol Renal Physiol. 2016;311:F1–F11. doi: 10.1152/ajprenal.00166.2016
  • Mathur M, Jones JR, Weinreb JC. Gadolinium deposition and nephrogenic systemic fibrosis: a Radiologist’s primer. Radiographics. 2020;40(1):153–162. doi: 10.1148/rg.2020190110
  • Fraum TJ, Ludwig DR, Bashir MR, et al. Gadolinium-based contrast agents: a comprehensive risk assessment. J Magn Reson Imaging. 2017;46(2):338–353. doi: 10.1002/jmri.25625
  • Steger-Hartmann T, Hofmeister R, Ernst R, et al. A review of preclinical safety data for magnevist (Gadopentetate Dimeglumine) in the context of nephrogenic systemic fibrosis. Invest Radiol. 2010;45:520–528. doi: 10.1097/rli.0b013e3181e960c9
  • Kaplan AP. Treatment of urticaria: a clinical and mechanistic approach. Curr Opin Allergy Clin Immunol. 2019;19:387–392. doi: 10.1097/ACI.0000000000000538
  • Dillman JR, Ellis JH, Cohan RH, et al. Frequency and severity of acute allergic-like reactions to gadolinium-containing i.V. contrast media in children and adults. AJR Am J Roentgenol. 2007;189(6):1533–1538. doi: 10.2214/AJR.07.2554
  • Prince MR, Zhang H, Zou Z, et al. Incidence of immediate gadolinium contrast media reactions. AJR Am J Roentgenol. 2011;196(2):W138–W143. doi: 10.2214/AJR.10.4885
  • Murphy KPJ, Szopinski KT, Cohan RH, et al. Occurrence of adverse reactions to gadolinium-based contrast material and management of patients at increased risk: a survey of the American Society of Neuroradiology Fellowship directors. Acad Radiol. 1999;6(11):656–664. doi: 10.1016/S1076-6332(99)80114-7
  • Nelson KL, Gifford LM, Lauber-Hauber C, et al. Clinical safety of gadopentetate dimeglumine. Radiology. 1995;196(2):439–443. doi: 10.1148/radiology.196.2.7617858
  • Ramalho J, Ramalho M. Gadolinium deposition and chronic toxicity. Magn Reson Imaging Clin N Am. 2017;25(4):765–778. doi: 10.1016/j.mric.2017.06.007
  • Quattrocchi CC, Van der Molen AJ. Gadolinium retention in the body and brain: is it time for an international joint research effort? Radiology. 2017;282(1):12–16. doi: 10.1148/radiol.2016161626
  • McDonald JS, Hunt CH, Kolbe AB, et al. Acute adverse events following gadolinium-based contrast agent administration: a single-center retrospective study of 281945 injections. Radiology. 2019;292(3):620–627. doi: 10.1148/radiol.2019182834
  • Deng SX, Castelo M, Reel E, et al. High risk breast cancer screening is a Double Edged Sword: a qualitative study of patient perspectives on the Ontario high risk breast cancer screening program. Clin Breast Cancer. 2022;22(8):812–822. doi: 10.1016/j.clbc.2022.08.004
  • Wang LY, Liao LF, Lei CL, et al. Data mining for signal detection of adverse events for taxanes based on the Food and drug administration adverse drug events reporting system database. Expert Opin Drug Saf. 2023;22(9):833–839. doi: 10.1080/14740338.2023.2203487
  • Bower DV, Richter JK, Tengg-Kobligk HV, et al. Gadolinium-based MRI contrast agents induce mitochondrial toxicity and cell death in human neurons, and toxicity increases with reduced kinetic stability of the agent. Invest Radiol. 2019;54(8):453–463. doi: 10.1097/RLI.0000000000000567

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.