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July 27, 2015: FDA Evaluating the Risk of Brain Deposits With Repeated Us Of Gadolinium-Based MRI Contrast Agents

The U.S. Food and Drug Administration (FDA) is evaluating the risk of brain deposits in patients who have been exposed to repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). According to the FDA, recent reports in the medical literature indicate that deposits of GBCAs remain in the brains of some patients who undergo four or more MRIs long after the contrast agent has been administered. It is unknown at this time whether or not these gadolinium deposits pose a health risk to patients.

What the FDA is Doing to Address this Issue

The FDA and its National Center for Toxicological Research (NCTR), will study potential safety risks by working with the research community and industry to describe the mechanism of gadolinium retention, and to determine if there are any potential adverse health effects.

At this time manufacturers are not required to make changes to GBCA lableing.

FDA Recommendations Regarding the Use of Gadolinium-Based Contrast Agents

The FDA made the following recommendations to reduce the potential for gadolinium accumulation:

β€œTo reduce the potential for gadolinium accumulation, health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary. Health care professionals are also urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols.

Patients, parents, and caregivers should talk to their health care professionals if they have any questions about the use of GBCAs with MRIs. This issue affects only GBCAs; it does not apply to other types of scanning agents used for other imaging procedures, such as those that are iodine-based or radioisotopes.”

Health care professionals, patients, and parents/caregivers are encouraged to report possible side effects involving GBCAs to the FDA MedWatch program.

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