What is Gadolinium? Plus a New FDA Retention Warning

Gadolinium is a liquid, man-made heavy-metal substance used in MRI and MRA scans. It is part of a gadolinium-based contrast agent (GBCA), which is used to make images in MRI scans clearer. Gadolinium-based contrast agents are given via an intravenous injection that generally takes between 10 and 30 seconds.

Currently, the US Food and Drug Administration (FDA) has approved two types of GBCAs for use: linear and macrocyclic agents. Of the two, linear agents have been found to be more strongly associated with gadolinium retention. Approximately 30 percent of MRI procedures involve the use of gadolinium contrast media (also known as gadolinium contrast dye).

What Conditions has Gadolinium Been Linked to?

Gadolinium has been linked to Gadolinium Deposition Disease, in which patients who have normal or near-normal kidney function develop signs of gadolinium retention in the hours to months after the dye is administered. Such symptoms include tissue burning, bone pain, and brain fog. Disease progression can lead to skin thickening and/or discoloration.

In addition to Gadolinium Deposition Disease, the contrast agent has been linked to Nephrogenic Systemic Fibrosis and Gadolinium Storage Disease.

FDA Issues Gadolinium Warning

Recently, the US Food and Drug Administration (FDA) issued a new warning regarding the use of Gadolinium-based contrast agents (GBCAs). In the warning, the FDA notes that it is requiring all GBCAs to carry a warning concerning the risk of gadolinium retention in patients–including in their brain–for months to years after exposure to the drugs.

Among the safety precautions the FDA requires to alert patients and healthcare professionals about the risks is a new Patient Medication Guide that will be given to every patient before the GBCA is administered. Furthermore, the makers of GBCAs are required to conduct human and animal studies to obtain more information on the safety of the drugs.

The FDA noted in its announcement that it had received reports of adverse events in patients with normal kidney function who were exposed to a GBCA, but had not established a causal association with gadolinium.

The FDA’s announcement came after a 2017 meeting of the Medical Imaging Drugs Advisory Committee (MIDAC), which voted to add more warnings to gadolinium-based contrast agents. Although committee members claimed there was not enough evidence to show the symptoms of gadolinium retention were caused by gadolinium, they were still concerned enough to warn patients about the risk.

Gadolinium Attorney

In October 2016, Cutter Law, P.C. filed the first lawsuit against a gadolinium-based contrast agent manufacturer alleging the dye is linked to gadolinium retention. Our firm has since filed numerous lawsuits in both state and federal court alleging patients were not properly warned about the risks associated with the use of GBCAs.

If you or a loved one has experienced gadolinium retention, please contact one of our attorneys to discuss your situation. Our attorneys can answer your questions and advise you of your rights.


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