FDA Issues Tougher Warning on MRI Dye Tied to Brain Effects

From Drugs.com - December 19, 2017

FDA Issues Tougher Warning on MRI Dye Tied to Brain Effects

TUESDAY, Dec. 19, 2017 -- The U.S. Food and Drug Administration on Tuesday called for tougher warnings and "additional research" into a dye commonly used with standard MRIs.

The dye -- a "contrast agent" -- contains a metal called gadolinium. It made news recently after claims from actor Chuck Norris that its use during MRI scans seriously affected his wife's brain.

Contrast agents are injected into the body during an MRI scan to enhance image quality.

In November, Norris and his wife, Gena, filed a lawsuit against several medical companies alleging she fell ill after exposure to gadolinium during MRI scans.

The suit said Gena Norris was left weak, tired and suffering bouts of pain and burning sensations.

After reviewing available data, the FDA on Tuesday recommended that radiologists consider how much gadolinium might be left behind in a patient's body when selecting a gadolinium-based contrast agent [GBCA] for an MRI.

The recommendation is especially important "for patients who may be at higher risk, such as those who may require repeat GBCA MRI scans to monitor a chronic condition," explained Dr. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research.

Patients who are sent for an MRI should also now receive a medication guide outlining issues surrounding gadolinium, Woodcock added.

But for most patients, "gadolinium retention has not been directly linked to adverse health effects," the FDA stressed in an agency news release. It also said "the benefit of all approved GBCAs continues to outweigh any potential risks."

For now, the FDA says gadolinium agents have only one known health risk: A "small subgroup" of kidney failure patients has developed a rare skin condition that causes a painful thickening of the skin.

But gadolinium can linger in the body "for months or years after receiving the drug," the agency said, noting more research is warranted. It is asking manufacturers of GBCAs to "also conduct human and animal studies to further assess the safety of these contrast agents."

This is not the agency's first warning on gadolinium. In September, an FDA panel called for a warning to be added to the agents' labels. The warning specifies that trace amounts of gadolinium may be retained in various organs, including the skin, bone and brain.

The big question remains, though: What, if any, are the harms?

Doctors have used gadolinium-based agents for 30 years -- totaling more than 300 million doses, said Dr. Vikas Gulani. He's an associate professor of radiology at Case Western Reserve University in Cleveland.


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