According to a gadolinium FDA warning, some patients who were injected with gadolinium contrast dye may retain the chemical in their bodies for months to years.

Gadolinium is a heavy chemical element associated with MRI medical scans. It is used as a contrast agent to make medical scans become more clear. The gadolinium FDA warning was released in December 2017.

As a result, the FDA now requires new patient information for the contrast dyes that are used in MRI, or magnetic resonance imaging scans. The European Medicines Agency (EMA), however, recommended the discontinued use of three of these agents altogether until demonstrations can be made of their safety and effectiveness.

Known for their public criticism of the MRI dyes, or gadolinium-based contrast agents, are actor Chuck Norris and his wife Gena. The couple filed a lawsuit in San Francisco Superior Court alleging that Gena Norris suffered gadolinium poisoning. She says that she was poisoned after intravenously receiving GBCAs prior to being administered three MRI scans in 2012 in a single week.

According to the lawsuit, Gena’s injuries as a result of gadolinium poisoning include “cognitive deficits; body pain and burning; kidney damage; loss of energy and mobility; and difficulty breathing due to rib damage.”

To treat Gina’s alleged gadolinium poisoning, the couple say they have shelled out almost $2 million. In damages, they are seeking more than $10 billion against the manufacturers who allegedly caused her gadolinium poisoning.

According to the gadolinium FDA warning patients who were contrasted with gadolinium may retain the chemical in their bodies for months to years. Patients have reported adverse side effects linked to gadolinium, including:

• Memory impairment
• Bone and joint pain
• Spongy or rubbery skin
• Thickened and painful ligaments
• Tightness in the hands and feet
• Headaches
• Cognitive difficulties or “brain fog”
• Pain and burning sensation in the arms, legs and torso

According to the gadolinium FDA warning, however “gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.” Those with pre-existing kidney problems may also suffer from a rare condition known as nephrogenic systemic fibrosis (NSF).

The gadolinium FDA warning is requiring a warning label on all nine approved GBCAs. The warning label will notify healthcare professionals that even months to years after an MRI, gadolinium can be retained in the body.

Patients will also receive a “Medication Guide” before they are to receive a GBCA that will inform them about gadolinium retention.

In Gina’s statement, she says, “Unfortunately, litigation is the only course of action we can take to hold the drug companies accountable for threatening the lives of so many innocent people who undergo MRIs. These companies continue to say that there is no link between gadolinium and adverse events, even though the evidence is overwhelming that this heavy metal stays in the body for years, rather than hours.”