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European Radiology
Erschienen in: European Radiology 4/2018

23.10.2017 | Contrast Media

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

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

Erschienen in: European Radiology | Ausgabe 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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Metadaten
Titel
Gadolinium retention after administration of contrast agents based on linear chelators and the recommendations of the European Medicines Agency
verfasst von
Ilona A. Dekkers
Rick Roos
Aart J. van der Molen
Publikationsdatum
23.10.2017
Verlag
Springer Berlin Heidelberg
Erschienen in
European Radiology / Ausgabe 4/2018
Print ISSN: 0938-7994
Elektronische ISSN: 1432-1084
DOI
https://doi.org/10.1007/s00330-017-5065-8

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