MRI Contrast Agent Use Linked to Brain Deposits

The U.S. Food and Drug Administration (FDA) has issued a safety alert on the risks connected to using gadolinium-based contrast agents (GBCAs) in magnetic resonance imaging (MRI), and is examining the potential danger of brain deposits occurring after repeated use of these agents.

After being administered, GBCAs are mostly eliminated from the body via the kidneys. However, trace amounts of gadolinium may remain in the body for the long-term, according to the FDA, which notes that recent studies have confirmed that gadolinium can remain in the brain, even in patients with normal kidney function.
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To reduce the potential for gadolinium accumulation, the FDA is advising healthcare providers to consider limiting the use of GBCAs to cases in which the contrast is required to gain additional clinical data, and is discouraging repetitive use of the agents, citing research that has found deposits of the agents in the brains of patients who have had at least four contrast MRI scans.  

According to a recent statement, the FDA—including its National Center for Toxicological Research (NCTR)—will continue to study this possible safety risk, and is “working with the research community and industry to understand the mechanism of gadolinium retention, and to determine if there are any potential adverse health effects.” Based on this need for additional information, the FDA is not currently requiring manufacturers to make changes to the labels of gadolinium-based contrast agent products.

In addition to urging patients, family members and caregivers to discuss questions about the use of gadolinium-based agents for MRIs with their healthcare providers, FDA Spokesperson Stephen King encourages providers as well as the general public to sign up for MedWatch Safety Alerts at www.fda.gov, in order to receive new safety information on human drugs, medical devices, vaccines, and other biologics, dietary supplements, and cosmetics.

In the meantime, “the FDA will continue to work with the industry and clinicians to investigate this issue,” says King, “and will update the public when more information is available.”

—Mark McGraw