Patient advocates are investigating claims of gadolinium toxicity after patients reportedly had adverse reactions to an MRI contrast agent.

These gadolinium toxicity symptoms have been informally referred to as “gadolinium deposition disease,” a set of symptoms that patients say can seriously worsen their medical condition. These reported incidents had spurred the FDA to issue a public warning in December 2017, which stated that patients who had recently gone an MRI using gadolinium based contrast may be at risk for gadolinium toxicity symptoms.

The FDA issued a communication in December 2017, warning patients about the possibility of gadolinium retention in their bodies after the MRI is completed. The warning notes that gadolinium toxicity symptoms can cause severe debilitating injuries, including the rare nephrogenic systemic fibrosis (NSF) in patients with pre-existing kidney problems.

The FDA also noted that adverse events involving multiple organ systems have been reported in patients with healthy kidneys, soon after experiencing gadolinium toxicity symptoms.

Overview of Gadolinium Toxicity Symptoms

Gadolinium-based contrast agents are used as contrast fluids for MRI procedures that are administered intravenously, because the fluid can enhance the images of the veins and internal organs shown on the images. Gadolinium is a heavy metal introduced into the bloodstream because it interacts strongly with the magnetic imaging of the MRI.

After the MRI is completed, the gadolinium based contrast agent is filtered through the patient’s kidneys and is supposed to be expelled from the body through urination. Even though gadolinium based contrast fluids are reliable for MRI images, it has allegedly caused serious health problems in patients.

One of the consequences of gadolinium toxicity symptoms is a set of symptoms that some patients call “gadolinium deposition disease,” which allegedly occurs when the metal material compounds in the patient’s organs and bones. Reported gadolinium toxicity symptoms include:

• Skin thickens and becomes discolored
• Sharp or burning sensations in lower limbs
• Mental confusion
• Tightness in feet or hands
• Joint pain
• Bone pain
• Head pain
• Neck Pain
• Vision problems
• Hearing problems
• Hair loss
• Irritated Skin
• Diarrhea
• Nausea
• Vomiting
• Breathing Problems
• Chronic headaches

Health officials have been concerned over the effects of gadolinium based contrast agents, with the FDA issuing several safety warnings that had required the drug’s warning label to be updated including:

• Sept. 9, 2010 (later revised on Dec. 23, 2010): FDA released a warning that stated that gadolinium based contrast fluids should not be administered to patients with a history of kidney failure.
• July 7, 2015: The FDA released additional warnings regarding gadolinium based contrast agents, stating that the agency would be evaluating the risk of gadolinium deposits compounding in patients’ brains.
• Dec. 19, 2017: The FDA states that new class warnings will be required for gadolinium based contrast agents, after reviewing post market safety reports and a review and consultation with the Medical Imaging Drugs Advisory Committee. The warnings stated that gadolinium deposits could be “retained in the body” and “may stay in the body long term.”

In addition to the FDA warnings, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued two recalls of gadolinium based contrast agents, Omniscan and Magnevist, in February 2018. The concern of gadolinium toxicity symptoms has spread throughout the United States and Europe, leaving health officials very concerned for patient safety.