South Korea Bans Certain Gadolinium MRI Contrast Dyes Amid Safety Concerns

Published on August 16, 2018 by Sandy Liebhard

As gadolinium MRI contrast dye lawsuits continue to mount in courts throughout the United States, concerns that the drugs might accumulate in the brain have prompted health regulators in South Korea to announce a temporary ban on linear gadolinium agents.

The ban affects a total of 13 linear agents, including Omniscan, Magnevist, and OptiMark.

South Korea’s Ministry of Food and Drug Safety has indicated that the ban will be in effect until the end of 2018.

European regulators suspended the use of some gadolinium agents in brain and spinal MRI scans last year due to similar concerns. However, they are still in use in the United States, as well as Canada, Japan, and Switzerland.

What are Gadolinium MRI Contrast Dyes?

Gadolinium-based dyes are injected just prior to an MRI to improve the visibility of organs, tumors, and blood vessels on imaging scans. The U.S. Food & Drug Administration (FDA) has approved 8 such agents for use in this country, including the following linear agents:

• Eovist
• Magnevist
• Multihance
• Omniscan
• OptimMARK

Macrocylic gadolinium agents available in the United States include.

• Dotarem
• Gadavist
• Prohance

Gadolinium Side Effects

In 2007, the FDA warned against the use of gadolinium-based contrast dyes in people with end-stage kidney disease, after the products were linked to a debilitating disease called nephrogenic systemic fibrosis, or NSF. The agents were considered safe for other patients.

Recently, however, a growing body of research has indicated that toxic gadolinium deposits can remain in the brain and elsewhere in the body weeks, months, and even years, after an MRI, prompting the FDA to add new warnings to the labels of all gadolinium-based contrast dyes in December 2017. Among other things, the agency noted that the risk of retention appeared to be greater with linear gadolinium agents.

While the FDA has not yet concluded that gadolinium retention poses a risk of adverse health consequences, it has advised health care professionals to consider the retention characteristics of each agent when choosing a gadolinium product for patients who may be at higher risk for retention, including:

• Patients requiring multiple lifetime doses
• Pregnant women
• Children
• Patients with inflammatory conditions

The FDA also ordered manufacturers of gadolinium-based contrast dyes to conduct animal and human studies to better evaluate the safety of these products.

Gadolinium Deposition Disease

A number of gadolinium contrast dye lawsuits involving NSF have already resulted in settlements. However, the makers of these drugs are now facing mounting  legal claims for Gadolinium Deposition Disease, an illnesses allegedly caused by the retention of gadolinium in the brain and other organs.

Symptoms of the disorder are purported to include:

• Intense burning of the skin and skin substrate
• Intense boring pain in bones or joints
• Brain fog or mental confusion
• Muscle vibrations, pins and needles sensation
• Headache
• Thickening, discoloration, pain in the skin or skin substrate of the distal arms and legs

Plaintiffs claim that the risks of gadolinium retention have long been known by the makers of the agents and accuse the companies of failing to warn patients and doctors of the danger.