Gadolinium Brain Deposit Risks Following MRI With Contrast Reviewed by FDA

Federal regulators are investigating the potential risk that gadolinium-based contrast agents (GBCAs), which are used to improve magnetic resonance imaging (MRI) results, may leave metal deposits in the brain. 

In a safety communication issued on July 27, the FDA announced that it has launched an investigation to review the findings of a recent recent that has suggested MRI contrast agents may cause a build up of gadolinium on the brain. The agency is reviewing whether the findings are accurate, and whether such deposits are harmful.

Two recent studies found that such gadolinium deposits occur, usually with multiple MRI examinations with contrast.

In March, a study published in the medical journal Radiology examined the brains of cadavers and found that those who had received gadolinium injections had deposits in the brain, while those who had not received such injections did not.

In June, a study by European researchers in the journal Investigative Radiology found similar deposits in the brains of rats injected with Omniscan, a GBCA (gadolinium-based contrast agent) made by GE Healthcare. The rats developed significant, persistent MRI abnormalities over time, and high levels of gadolinium were found deep in the rats’ brains.

The FDA says that it will use its National Center for Toxicological Research to study the potential safety risks further, but is currently taking no action.

“We are 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,” the drug safety communication states. “Based on the need for additional information, at this time, we are not requiring manufacturers to make changes to the labels of GBCA products.”

The agency is urging healthcare professionals and patients to report any possible side effects involving GBCAs to the MedWatch adverse event reporting program.

Gadolinium Contrast Safety Concerns

Gadolinium-based contrast agents are solutions given to patients before they take a MRI in order to get better results. Although the MRI dyes are generally believed to be safe, several years ago concerns emerged about a link between MRI gadolinium contrast agents and a severe and life-threatening skin condition, known as nephrogenic systemic fibrosis (NSF), which was found to occur among patients with impaired kidney function, causing their skin to thicken and harden, severely restricting movement.

Sometimes referred to as gadolinium associated systemic fibrosis, NSF is a painful disorder that has no known cure and often results in confinement to a wheelchair and then death.

In 2007, the FDA limited gadolinium contrast doses in most patients and contraindicated it for others, which limited the risk of NSF. In September 2010, the FDA went even further and banned the use of Bayer’s Magnevist on patients with kidney problems, due to the heightened risk of NSF. The agency also put similar restrictions on GE Healthcare’s Omniscan and Covidien’s Optimark.

The agency also required label changes for all GBCAs, warning healthcare professionals to screen patients before injecting gadolinium to identify those suffering from acute kidney injury or chronic, severe kidney disease.