The FDA issued a safety warning regarding gadolinium contrast agents in December 2017, stating that some patients may have suffered severe toxicity effects.

Gadolinium contrast agents are heavy metal based materials that are used for MRI diagnostic images scans, which help enhance the images of organs, blood vessels, and tissues to help doctors make accurate diagnostic conclusions.

The magnetic properties of the gadolinium contrast agents help improve MRI images. However, gadolinium contrast agents have reportedly been associated with a number of serious complications in patients who say the metal stayed in their bodies long after the MRI was completed.

Overview of Toxicity Problems with Gadolinium Contrast Agents

In its warning, the FDA stated that gadolinium toxicity can cause a rare disease called nephrogenic system fibrosis (NSF), which has been reported in patients with pre-existing kidney problems. In addition, the FDA says it has also received injury reports describing multi-organ failure from patients with normal kidney function.

While NSF has been on the black box warning label of gadolinium contrast agents for years, gadolinium toxicity in patients with healthy kidney function is of concern.

One of the complications reported by patients with normal kidney function is known as gadolinium deposition disease (GDD), which allegedly occurs when the metal accumulates in the body and typically manifests within weeks or months after exposure.

Gadolinium and other contrast agents are typically expelled from the body through the kidneys, but some patients believe they can be toxic if the metal is retained. This is especially true in cases of gadolinium retention in the brain, which may be linked to problems in the upper and lower limbs along with cognitive difficulties.

The side effects reported in conjunction with gadolinium contrast agents include:

• Pain and burning sensations in arms, legs, and torso
• Cognitive difficulties
• Headaches
• Memory impairment
• Bone and joint pain
• Spongy or rubbery skin
• Thickened and painful ligaments
• Tightness in hands and feet

According to the recent FDA warning, the agency will require new class warnings and safety precautions for all gadolinium contrast agents. The new warning label will reportedly include information about “gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs.”

Even with these warnings, the FDA stated that the benefits of gadolinium contrast agents outweighed the potential risks. However, the FDA acknowledges in its warning that the new regulations will help increase awareness of the potential complications associated with gadolinium contrast agents.

“[A]fter additional review and consultation with the Medical Imaging Drugs Advisory Committee, we are requiring several actions to alert healthcare professionals and patients about gadolinium retention after an MRI using a GBCA, and actions that can help minimize problems. [W]e are also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents,” the FDA warning states.

Gadolinium contrast agents gained major media attention in November 2017, after actor Chuck Norris filed legal action with his wife Gena, who allegedly developed toxicity reactions from an MRI contrast agent.