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European Radiology
Published in: European Radiology 4/2018

01-04-2018 | Contrast Media

Gadolinium retention after administration of contrast agents based on linear chelators and the recommendations of the European Medicines Agency

Authors: Ilona A. Dekkers, Rick Roos, Aart J. van der Molen

Published in: European Radiology | Issue 4/2018

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Abstract

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) earlier this year recommended to suspend some marketing authorisations for Gadolinium Containing Contrast Agents (GCCAs) based on linear chelators due to the potential risk of gadolinium retention in the human body. These recommendations have recently been re-evaluated by EMA’s Committee for Medicinal Products for Human Use (CHMP), and confirmed the final opinion of the European Medicines Agency. This editorial provides an overview of the available GCCAs and summarises the recent evidence of gadolinium retention. Moreover, a critical appraisal of the strengths and limitations of the scientific evidence currently available on gadolinium retention is given.

Key points

• EMA recommended suspension of some EU marketing authorisations of four linear GCCAs.
• Brain MRI findings indicating gadolinium retention have been confirmed by mass spectrometry.
• Current scientific evidence for gadolinium retention has several methodological limitations.
• No clear clinical evidence exists indicating that gadolinium retention causes neurotoxicity.
• Long-term safety of GCCAs, however, remains unclear.
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Metadata
Title
Gadolinium retention after administration of contrast agents based on linear chelators and the recommendations of the European Medicines Agency
Authors
Ilona A. Dekkers
Rick Roos
Aart J. van der Molen
Publication date
01-04-2018
Publisher
Springer Berlin Heidelberg
Published in
European Radiology / Issue 4/2018
Print ISSN: 0938-7994
Electronic ISSN: 1432-1084
DOI
https://doi.org/10.1007/s00330-017-5065-8

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