FDA Investigates Gadolinium-based Contrast Agents

February 21, 2018 Laura Hale Brockway

The Food and Drug Administration (FDA) has initiated an investigation into the health risk of brain deposits following repeated use of gadolinium-based contrast units (GBCAs) for MRI. Recent medical publications report that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration. It is unknown whether these GBCA deposits are harmful or lead to adverse effects. 

GBCAs are mostly eliminated through the kidneys after an MRI. However, studies have confirmed that trace amounts of gadolinium can remain in the brain long-term, even in patients with normal kidney function. This issue affects only GBCAs; it does not apply to other types of scanning agents, such as those that are iodine-based or radioisotopes.

The FDA recommends that health care professionals consider limiting GBCA to clinical circumstances in which the additional information provided by the contrast is necessary. The FDA also urges health care professionals to reassess the use of mrepetitive GBCA MRIs in established treatment protocols. 

The full, original report, including information on how to report adverse events or side effects related to GBCA use, is available on the FDA website.

About the Author

Laura Hale Brockway is the Assistant Vice President of Marketing at TMLT. She can be reached at laura-brockway@tmlt.org.

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