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Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI) - FDA Evaluating Risk of Brain Deposits with Repeated Use

July 29, 2015

FDA is evaluating the safety risk of brain deposits resulting from repeated use of gadolinium-based contrast agents (GBCAs). Gadolinium-based contrast agents are used for magnetic resonance imaging (MRI) procedures to enhance the visualization of abnormalities in the body. The health risks associated with GBCA brain deposits are currently unknown. In reports from the published literature, gadolinium deposits were found in the brain of some patients who had undergone four or more GBCA MRI scans. This issue does not apply to other contrast agents (eg, iodine-based agents, radioisotopes). Gadolinium-based contrast agents are primarily cleared by renal elimination; however, gadolinium deposits can remain in the brain despite normal renal function. No adverse health effects related to GBCA brain deposits have been identified in the available literature. The following are FDA approved GBCAs:

  • Gadobenate dimeglumine (MultiHance)
  • Gadobutrol (Gadavist)
  • Gadodiamide (Omniscan)
  • Gadofosveset trisodium (Ablavar)
  • Gadopentetate dimeglumine (Magnevist)
  • Gadoterate meglumine (Dotarem)
  • Gadoteritol (ProHance)
  • Gadoversetamide injection (OptiMARK)
  • Gadoxetate disodium (Eovist)

There are no changes in the product labeling of GBCA products at this time. FDA is continuing to investigate this issue and will provide an update when additional information is available. Limit the use of GBCAs to clinical situations where additional information provided by GBCAs is required. FDA recommends health care professionals reevaluate the necessity of repeated GCBA MRIs in treatment protocols. Patients are encouraged to communicate any questions they have about GBCAs to their healthcare professionals. Report adverse events related to GBCAs to the FDA MedWatch Program.
Additional information:

July 29 2015; University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.