New Gadolinium Medication Guide Issued at FDA Request

Some MRI patients will receive a new medication guide for gadolinium-based contrast agents (GBCAs)—dyes used in many MRIs—after the Food and Drug Administration (FDA) issued a new warning about the agents. The FDA issued the warning after receiving reports that gadolinium may linger in the brain for months and even years after injection.

Part of the FDA’s warning required a new medication guide to accompany GBCA injections. The agency has now approved those updated guides, which will be given to outpatients getting magnetic resonance imaging (MRI) at a center. The new gadolinium guides are not required for hospital patients.

New Warning Addresses Potential Long-Term Gadolinium Retention

The new GBCA medication guides were one of the results of a December 19, 2017, FDA safety alert that gave the drug a new class warning. The safety agency has a long history with gadolinium, dating back to 2010 when they first highlighted possible problems from gadolinium for those with kidney failure.

The FDA issued the December 2017 safety alert about GBCAs, which are used in some patients who undergo an MRI, due to findings that the gadolinium in the agents linger longer in patients’ bodies than they had previously thought. While the safety agency did point out that studies have yet to directly link adverse health effects in patients with kidney issues, it does not mean there are no risks that come with long-term gadolinium exposure. Multiple conditions have already been linked to gadolinium.

Healthcare professionals may now provide new outpatients receiving treatment at MRI centers with the latest Medication Guide before they are to be treated with GBCAs. Further studies will also be done to determine other risks and factors of gadolinium-based treatments.

The FDA-approved Medication Guide will alert patients to the fact that:

Gadolinium is retained for months or years in several organs. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver, and spleen).

The guide also notes that the consequences of gadolinium retention in the brain have not yet been established.

Types of Injections Affected

The agents affected by the new gadolinium warning and accompanying medication guide are all injections. Their brand names are:

· Dotarem®

· Eovist®

· Gadavist®

· Magnevist®

· MultiHance®

· Omniscan™

· Optimark®

· ProHance®

Radiology Journal Publishes Gadolinium Study Results

At the same time that the FDA approved the new GBCA medication guide, Radiology, a specialized health and science journal, published the results of a year-long study into the brain’s retention of gadolinium, focusing on comparing gadodiamide and gadoterate, using rodents as test subjects.

The study’s authors gave the rodents repeated doses of gadolinium over the course of the study, while running numerous tests and taking samples from the animals, in hopes of gaining more of an understanding on how bodies process gadolinium, which is toxic, but used in about 30 percent of MRI scans.

The study’s conclusions confirmed the FDA’s findings, with the authors saying, “after repeated administration of gadodiamide, a large portion of gadolinium was retained in the brain.” With multiple injections of gadoterate, the authors detected “only traces of the intact chelated gadolinium” following observation with time-dependent clearance.

GBCA Injections Linked to Gadolinium Deposition Disease 

The concerns about the lengthy gadolinium retention focus on the conditions its presence could cause or exacerbate. This is especially concerning in those patients who have been given many injections over the course of their lifetime, or in pregnant women, children, and patients with inflammatory conditions.

One of the conditions that is most often referenced with gadolinium use is nephrogenic systemic fibrosis or NSF. It is found in patients with lower functioning kidneys and is caused by the patient’s inability to remove the gadolinium from their body, because of their compromised kidneys. Symptoms can include thickening and darkening of the skin, and the condition can be fatal.

Gadolinium deposition disease is another major concern. It occurs in people with normal or near-normal kidney function and can appear mere hours or months after an injection with a GBCA. Patients will often experience a burning sensation in their tissue, pain in their bones, and brain fog. The afflicted may have been in good health up until the introduction of gadolinium, and the disease can be difficult to properly diagnose.

Gena Norris, Wife of Chuck Norris, Has Been Vocal Victim of Disease

One of the most visible faces of gadolinium deposition disease has been Gena Norris, wife of actor Chuck Norris.

Gena was otherwise healthy when she received three MRI scans in an eight-day timespan (all with MultiHance or ProHance). Her symptoms started immediately after the scans, but, despite repeated hospital visits it took almost five years to obtain a gadolinium deposition disease diagnosis.

Gena has now filed a lawsuit against McKesson Corporation and other defendants alleging that the disease was the direct result of her exposure to gadolinium and that the corporation and other defendants knew or should have known about the risk of the disease but did not adequately warn patients and healthcare providers. Gena Norris is represented by Cutter Law, P.C.

If You Have Received an Injection with Gadolinium 

Gadolinium is now shown to linger in the body and brain for months and years after injection and may have devastating effects on your health and lifestyle. If you received a treatment with gadolinium and feel you have suffered negative consequences, contact the attorneys at Cutter Law to find out more about how to take action.

New Gadolinium Medication Guide Issued at FDA Request




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