Following an FDA gadolinium warning, contrast agent manufacturers face legal action and criticism claiming that they failed to warn about the risks associated with gadolinium retention.

Gadolinium-based contrast agents are used during MRI scans to improve the visualization of internal organs, blood vessels, and tissues. These agents can increase the clarity of an MRI image and help with the diagnoses of serious health concerns such as cancer, infections, and bleeding. The new FDA gadolinium warning aims to make the public more aware of the issues.

Usually, these contrast agents are eliminated from the body through the kidneys. However, trace amounts of gadolinium may be retained in the body long-term after administering any contrast agents. The retention of gadolinium in the body, particularly the brain, may be responsible for numerous health concerns including pain in the arms, legs, and torso; cognitive difficulties; headaches; impaired memory; bone and joint pain; skin problems; and painful ligaments.

In December 2017, an FDA gadolinium warning released the news that the federal agency would be requiring new class warnings and safety measures for all gadolinium-based contrast agents. The new FDA gadolinium warning statements would inform patients about “gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs.”

Gadolinium retention has been linked to a rare and dangerous condition known as nephrogenic systemic fibrosis (NSF). Individuals with NSF experience a thickening and darkening of large areas on the skin resembling skin diseases. The FDA has also received reports of multi-organ system failure as a gadolinium retention adverse event.

The FDA gadolinium warning determined that the benefits of using gadolinium contrast agents outweighed any potential risks. Although the FDA made this determination, the FDA gadolinium warning acknowledges that their new regulatory actions will help increase education about gadolinium retention.

“However, after 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,” the FDA gadolinium warning states. “We are also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.”

Although the FDA determined that gadolinium-based contrast agents are worth the risk, the FDA gadolinium warning acknowledged that these contrast agents may result in gadolinium retention in patients with normal kidney function.

Plaintiffs have already filed lawsuits over this issue, challenging manufacturer representation of gadolinium-based contrast agents and their safety profile. Some individuals claim that manufacturers knew or should have known about their products’ risks for gadolinium retention and related side effects including NSF in patients with healthy kidneys.

If you or a loved one experienced gadolinium retention and related side effects, you may be eligible to file a gadolinium lawsuit. A gadolinium lawsuit could hold manufacturers accountable for not warning patients and help recover compensation for medical expenses, pain and suffering, and more.