Patients who allegedly suffer from gadolinium poisoning are filing lawsuits against the makers of the MRI contrast dyes.

Gadolinium-based dyes often are used in Magnetic Resonance Imaging (MRI) medical tests because the heavy metal’s magnetic qualities allow doctors to see an enhanced view of the organs, tissues and blood vessels.

An MRI allows an electric current to pass through wire coils, creating a temporary magnetic field throughout the patient’s body. A transmitter/receiver in the device allows radio waves to create a digital image of the scanned part of the body.

The average MRI takes 20 to 90 minutes from start to finish. More and more patients allege they are experiencing gadolinium poisoning even though they have long been told that the gadolinium is excreted from the body through the urine within 24 hours.

The FDA says that a majority of the gadolinium is eliminated through the kidneys, but that “trace amounts of gadolinium may stay in the body long-term.”

Patients report the following symptoms they say are indications they are suffering from gadolinium poisoning:

• Random pain and burning sensations of the skin
• Joint and bone pain
• Central nervous system problems
• Skin rashes
• Thickening of the skin
• Constant headaches
• Fatigue
• Cognitive impairment, feeling like they are in a “fog”

Gadolinium poisoning is also referred to as gadolinium deposition disease.

Gadolinium Poisoning Possibilities

A decade ago, makers of the gadolinium-based contrast dyes were confronted with lawsuits by patients who had pre-existing kidney problems that prevented their bodies from fully eliminating the dye through their urine.

Now, patients with regularly functioning kidneys allege the gadolinium stays in their bodies and that the manufacturers of the dyes did not provide adequate warning of the risks of alleged gadolinium poisoning.

So far, the FDA has not found an association between any retention of gadolinium and resulting health problems in patients who have normal kidney function, but new safety measures will be required.

The FDA has mandated new label requirements accompany the contrast dyes, including a new Medication Guide that includes information about possible retention of gadolinium and potential side effects.

At the same time, the FDA has asked all manufacturers of gadolinium-based contrast agents to begin new studies on animals and humans to fully understand the implications of using the dyes.

In addition, the FDA has suggested patients who are pregnant or might be pregnant and those suffering from conditions marked by inflammation could be at a higher risk of complications.

The FDA also warns health care workers that gadolinium retention could be a factor when deciding whether to use contrast dyes in MRI tests on small children, patients previously diagnosed with kidney issues, and patients who recently underwent a similar MRI using a gadolinium-based contrast dye.

Current lawsuits allege the manufacturers gave patients false or misleading information regarding the safety profiles of contrast agents, which caused the patients to allegedly suffer gadolinium poisoning.

The most often used contrast dyes in the U.S. are Dotarem by Guerbet; Ecovist, Gadavist and Magnevist by Bayer, MultiHance and ProHance by Bracco; and Omniscan by GE Healthcare.

Hundreds more lawsuits against the gadolinium dye manufacturers are anticipated as patients become aware of the symptoms of gadolinium poisoning.