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FDA investigating risk of gadolinium contrast agent brain deposits


 

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The Food and Drug Administration is investigating the risk of brain deposits after recurring use of gadolinium-based contrast agents for MRI, the agency announced in a statement.

Studies suggest that gadolinium-based contrast agent (GBCA) deposits may stay in the brains of patients who have four or more contrast MRI scans, though it is unknown whether these deposits cause adverse effects, the FDA said.

GBCAs are usually expelled through the kidneys, but may remain in the brain after repeated exposure. FDA’s National Center for Toxicological

Research will further investigate safety risks in consultation with researchers and industry, the statement said.

The FDA is not requiring manufacturers to change the labels of GBCA products until more information is known. The agency is, however, recommending that clinicians limit GBCA use to situations in which it would be necessary for patient care.

“Health care professionals are also urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols,” the FDA said.

Patients may report side effects and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

mrajaraman@frontlinemedcom.com

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