The U.K. Royal College of Radiologists recently issued updated guidelines to address the risks associated with gadolinium-based MRI contrast dyes, especially recent concerns surrounding the possible retention of gadolinium in the brain and other parts of he boy.
The 23-page document contains eight recommendations that cover safety, prescribing, consent, identification of patients at increased risk from contrast administration, and pregnancy and lactation. It also provides guidance on the management and treatment of acute reactions.
Among other things, the report advises individuals administering gadolinium-based MRI contrast dyes to first check that there are no contraindications to its use and ensure that the patient understands that it is to be given and agrees to the procedure.
Essential information should be obtained from the patient prior to contrast injection, including any history of kidney problems or previous reactions to gadolinium-based MRI contrast dyes.
“In the presence of risk factors, the decision about contrast administration should only be taken by the radiologist responsible for the procedure,” the report notes. “This decision process should include the location of the proposed examination with reference to resuscitation capability,”
Finally, the guidelines recommend that the gadolinium dose be minimized, taking into consideration the indication, the patient’s body weight, and the information from the manufacturer contained in the summary of product characteristics.
The U.S. Food & Drug Administration (FDA) has approved eight gadolinium-based MRI contrast dyes for use in the United States:
These agents are injected prior to an MRI to enhance the appearance of images that appear on a scan.
Gadolinium-based agents are contraindicated for use in patients with kidney problems, as their inability to eliminate the toxin can cause a potentially deadly disease called Nephrogenic Systemic Fibrosis, or NSF. Until recently, however, gadolinium retention was not considered a concern for patients with healthy kidneys.
But in December 2017, the FDA warned that multiple recent studies had suggested gadolinium deposits might remain in the brain, tissue, organs, and skin, for months or years after an MRI, even in the absence of kidney problems. Although gadolinium retention hasn’t been directly linked to any negative health effects, pathological skin changes and adverse events involving multiple organ systems have been reported in patients with normal renal function.
Dozens of people across the United States have since filed lawsuits for Gadolinium Deposition Disease, a debilitating and potentially permanent disorder that allegedly occurs when gadolinium deposits accumulate in the body. Symptoms are said to include:
All of these plaintiffs claim that their kidneys were healthy when they underwent MRIs. They further allege that the manufacturers of gadolinium-based MRI contrast dyes have long been aware that retention is a risk for patients with normal renal function, put failed to provide the public and medical community with appropriate safety warnings.