The companies involved, stated the group, can ask PRAC to re-examine its findings and “the suspensions can be lifted if the respective companies provide evidence of new benefits in an identified patient group that outweigh its risks or show that their product (modified or not) does not release gadolinium significantly (dechelation) or lead to its retention in tissues,” it advised.

The potential risks associated with gadolinium have been under study for a number of years. And a study reported by HCB News in December, 2016, found that the brain deposits were lower with macrocyclic agents.


Researchers at the NeuroCure Clinical Research Center and Department of Radiology of Charité - Universitätsmedizin Berlin and the Max Delbrück Center for Molecular Medicine, looked at the issue in multiple sclerosis patients. According to author, Dr. Michael Scheel, they found that patients who received macrocyclic gadolinium-based contrast agents showed no evidence of gadolinium brain deposition.

The researchers go on to add that "available data currently suggest that the risk of deposits is considerably higher with contrast agents that have a linear molecular structure. This effect appears to be absent, or much reduced, when using contrast agents with a ring-shaped, macrocyclic structure."

Previous research had revealed that the rare-earth-based contrast agent deposits are “permanent,” noted the researchers.

The last ten years has seen gadolinium's reputation as “one of the safest drugs there was” come into question, Dr. Emanuel Kanal, a professor of radiology and the director of MR services at the University of Pittsburgh Medical Center, told HCB News in March, 2016.

In 2006, reports surfaced that use of FDA-approved GBCAs in people with renal woes could result in nephrogenic systemic fibrosis, which has no cure.

Then in 2013 came the first reports of its accumulation in the brain. “No one told us it would stay in the body,” said Kanal at the time. “They told us it had a half-life of 90 to 120 minutes and after 6 or 9 hours most of it is gone, and we assumed that after a day or two there’s no trace left.”

In related news, GE announced a new a macrocyclic MR imaging contrast medium, Clariscan (gadoteric acid), at the European Congress of Radiology (ECR) 2017 meeting.

“Gadolinium-based agents are known to be a gold-standard detection tool in MR imaging, offering improved contrast between normal and pathological tissue to enable rapid detection of abnormalities. It is important that radiologists are able to make a contrast media selection dependent on the needs of individual patients'” said Emmanuel Ligner, General Manager of Core Imaging for GE Healthcare Life Sciences, in a statement.

And in February, researchers at the Massachusetts Institute of Technology developed an alternative to gadolinium-based contrast agents for MR exams using iron oxide nanoparticles. Unlike gadolinium-based contrast agents, the coated iron oxide can clear from the kidney quickly and not accumulate. The combination of the very small iron oxide core and the ultrathin ligand shell yields a total hydrodynamic diameter of 4.7 nanometers, which is below the 5.5-nanometer renal clearance threshold.

Back to HCB News

MRI Homepage