FDA Safety Communication about Gadolinium-based Contrast Agents

PUBLISHED: May 23, 2017
Relevant to: Ambulatory Care, Hospitals, Medical Office/Clinic

A U.S. Food and Drug Administration (FDA) review to date has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). All GBCAs may be associated with some gadolinium retention in the brain and other body tissues. However, because the FDA identified no evidence to date that gadolinium retention in the brain from any of the GBCAs, including GBCAs associated with higher retention of gadolinium, is harmful, restricting GBCA use is not warranted at this time. The FDA is continuing to assess the safety of GBCAs and plan to have a public meeting to discuss this issue in the future.

The FDA’s recommendations for health care professionals and patients remain unchanged from July 2015 when they informed the public of the investigation into this potential risk with GBCAs. As is appropriate when considering the use of any medical imaging agent, health care professionals should limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs. Patients, parents, and caregivers should be advised to talk to their health care professionals if they have any questions or concerns about the use of GBCAs with MRIs. Retention of gadolinium affects only GBCAs, and does not apply to other types of scanning agents used for other imaging procedures, such as those that are iodine-based or radioisotopes.

Please see the FDA Safety Communication for additional information.

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