Following evidence that MRI contrast dyes may result in gadolinium brain deposits, the FDA has called for tougher warnings and further research into the contrast agent.

In December 2017, the U.S. Food and Drug Administration called for tougher warnings and “additional research” into the side effects of MRI contrast dyes and their potential to result in gadolinium brain deposits.

Gadolinium brain deposits made the news after actor Chuck Norris claimed that his wife sustained brain damage following a routine MRI. Norris and his wife Gena filed a lawsuit against numerous companies, seeking compensation for the damages she sustained. Gena reportedly suffers from weakness, fatigue, pain, and burning sensations, allegedly due to gadolinium brain deposits.

An MRI scans the human body using a powerful magnetic field and generates detailed pictures of organs, bones, and other internal structures. To enhance these images, gadolinium-based contrast agents are injected into blood stream. However, recent criticisms suggest that the risks for gadolinium brain deposits may make the use of such agents too risky.

In response to these criticisms, the FDA released a recommendation that radiologists administering MRI scans consider how much of the contrast agent to use and if it is necessary.

According to Dr. Janet Woodcock, the FDA’s director of the Center for Drug Evaluation and Research, told HealthDay the recommendation is important “for patients who may be at higher risk, such as those who may require repeat GBCA MRI scans to monitor a chronic condition.” Woodcock also stated that patients should now receive a medication guide regarding gadolinium brain deposits and other issues surrounding the contrast agents.

In its safety announcement, the agency stated that “gadolinium retention has not been directly linked to adverse health effects,” and that “the benefit of all approved GBCAs continues to outweigh any potential risks.”

However, the agency admits that the retention of gadolinium in the body warrants more research. In addition to their recommendations, the FDA has asked manufacturers to “conduct human and animal studies to further assess the safety of these contrast agents.”

Dr. Vikas Gulani, medical professional and associate professor of radiology at Case Western Reserve University, supports the call for research, according to HealthDay. In addition to his work as a doctor and professor, Gulani has assisted the International Society of Magnetic Resonance in Medicine in creating recommendations for the use of MRI contrast agents.

Gulani adds that scientists have only recently discovered that use of contrast agents may result in gadolinium brain deposits and other retention. The risks of gadolinium exposure are not fully understood, and further research may help doctors like himself do their jobs better.

Gulani also notes that contrast agents, while helpful, are not always needed and patients can ask their doctors whether or not it is truly needed. If a contrast agent is not needed, Gulani thinks that it shouldn’t be used. “It’s just like with any other medication,” Gulani said. “If you don’t need it, don’t use it.”