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On May 16, 2018, the FDA released an updated safety communication regarding gadolinium-based contrast agents (GBCAs), which are dyes injected into patients prior to magnetic resonance imaging (MRI). These dyes help make abnormal cells and tissues more visible, and are used to help doctors diagnose health issues like infections, bleeding, and cancer.

The FDA has been examining these dyes for years and has issued several warnings about their potential side effects. In this most recent update, the FDA approved new patient medication guides that include update warnings about the potential for the dyes to remain in the body for long periods of time.

FDA Has a History of Warning About Gadolinium-Based Contrast Agents

It started back in 2010, when the FDA warned that they were requiring new warnings on GBCAs concerning their potential to increase the risk of nephrogenic systemic fibrosis (NSF), a rare but serious condition associated with the use of these products in patients with kidney dysfunction. NSF is a disease that causes muscle weakness, swelling and tightening of the skin, bone pain, reduced organ function, and more.

The FDA found that in some patients at risk for kidney disease, GBCA use could trigger NSF. They advised healthcare professionals to avoid using these dyes in patients with severe, chronic kidney disease.

In 2015, the FDA announced that they were evaluating the risk of brain deposits in patients receiving repeated injections of GBCAs. Some studies at that point indicated that the dyes could remain in some patients’ brains who went through four or more MRI scans, long after the last administration. The FDA couldn’t say then whether the deposits were harmful.

GBCA manufacturers have maintained that the chemicals are flushed out the body via the kidneys and urine within just a few days of being administered. Studies, however, have contradicted that assertion.

FDA Continues to Evaluate Safety of GBCAs

The FDA continued to follow developments involving GBCAs, and on December 19, 2017, announced that they were requiring a new class warning on all dyes used for MRIs. The warnings alert doctors and patients to the possibility that gadolinium deposits can remain in the body, including the brain, for months to years after injection.

So far, the FDA has not linked these deposits directly to adverse health effects in patients with normal kidney function, and maintains that the benefits outweigh the risks. They did warn doctors, however, to be cautious in choosing dyes for patients who may be at a higher risk for retaining the gadolinium, including those receiving multiple doses over the course of a lifetime, pregnant women, patients with inflammatory conditions, and children.

The FDA continues to “assess the health effects of gadolinium retention in the body” and stated they will update the public when new information becomes available.

Some Patients Suffer from Gadolinium Deposition Disease

Meanwhile, many patients who received injections of GBCAs have complained of “gadolinium deposition disease,” a condition that has symptoms similar to NSF, but is not the same. Those with gadolinium deposition disease did not have preexisting kidney problems, yet still develop bone pain, brain fog, tissue burning, and other symptoms within hours to months after being exposed to gadolinium.

In May 2018, researchers published a study showing that gadolinium deposits in the brain were not dependent on the amount of dye administered, but could be affected by other factors such as the presence of brain tumors, or treatment with irradiation. Lead author, Benita Tamrazi, stated that there are a “lot of unknowns regarding gadolinium deposition in the brain….”

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