After a nearly 2-year review process, the US Food and Drug Administration (FDA) has not found any evidence of adverse events from the brain's retention of gadolinium after MRI that uses gadolinium-based contrast agents (GBCAs), the agency announced yesterday.
While many studies have given evidence that all GBCAs may be associated with some gadolinium retention in the brain and other body tissues, up to now such retention could not be linked to any adverse health effects. Accordingly, the FDA will not restrict the use of GBCAs, but it will continue to study their safety and will organize a public meeting to discuss this issue in the future, the agency said in a news release.
The FDA further affirms its recommendations from July 2015 for health care professionals, where it was already said that clinicians should limit their use to cases in which additional information yielded by the contrast agent is necessary and reassess the need for repetitive MRIs with GBCAs.
There are two different types of GBCAs, having linear or macrocyclic ligands. A review of the studies related to retention of GBCAs in different organs has revealed that that linear GBCAs retain more gadolinium in the brain than macrocyclic GBCAs. However, FDA's review did not identify adverse health effects related to this brain retention.
Gadolinium, a heavy metal, can be retained not only in the brain but also in other parts of the body such as in bone and skin. To date, the only identified adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure that is responsible for limited excretion of GBCAs. FDA is also reviewing studies reporting of patients with normal kidneys who developed NSF after receiving GBCAs for an MRI. Some of these patients had retained gadolinium in their brains as well.
In order to support the ongoing review process, the FDA is urging patients and health care professionals to report side effects involving GBCAs or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page:
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
Related studies (newest first)
Jennifer S. McDonald, Robert J. McDonald, Mark E. Jentoft, Michael A. Paolini, David L. Murray, David F. Kallmes, Laurence J. Eckel,
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Related information
EMA: European Medicines Agency. Gadolinium-containing contrast agents EMA:
March 10, 2017: PRAC concludes assessment of gadolinium agents used in
body scans and recommends regulatory actions, including suspension for
some marketing authorisations EMA: March 8, 2016: PRAC reviews gadolinium contrast agents used in MRI scans FDA: Information on Gadolinium-Based Contrast Agents FDA:
July 27, 2015: FDA evaluating the risk of brain deposits with repeated
use of gadolinium-based contrast agents for magnetic resonance imaging
(MRI)
Related EVISA Resources
Brief summary: Speciation analysis for the study of metallodrugs and their biomolecular interactions Link Database: Toxicity of Gadolinium compounds
Link database: Use of Gadolinium in pharmaceuticals
Materials Database: Gadolinium Materials
Link page: All about Mass Spectrometry: Resources related to Mass Spectrometry 
Related EVISA News
March 11, 2017: European Medicines Agency recommends to pull linear Gadolinium-based MRI contrast agents from market April 10, 2016: New Studies Question Safety of MRI Contrast Agents August 13, 2015: FDA investigating risk of gadolinium contrast agent brain deposits March 4, 2015: Detection of Gd-based contrast agent in the skin of a patient eight years after administration October 29, 2012: Identification and quantification of potential metabolites of Gd-based contrast agents September 15, 2010: US FDA Announces Gadolinium-Based MRI Contrast Agent Warning March 25, 2010: Publication on the separation of Gd-based contrast agents awarded May 4, 2009: Gadolinium speciation analysis in search for the cause of nephrogenic systemic fibrosis (NSF) last time modified: September 23, 2024
