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FDA in Brief: FDA requires new class warning and additional research on retention in the body of gadolinium from gadolinium-based contrast agents used in magnetic resonance imaging

For Immediate Release: December 19, 2017

Media Inquiries
 Lauren Smith Dyer
 301-348-1888

"The FDA reviewed available data about the retention of gadolinium from gadolinium-based contrast agents as part of its role in monitoring the post-market safety of drugs. As a result of that review, we recommend that health care professionals consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk, such as those who may require repeat GBCA MRI scans to monitor a chronic condition. We are requiring a class-wide warning about gadolinium retention in the labeling of GBCAs and a new medication guide that should be presented to patients in advance of receiving a GBCA," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. "The FDA will continue to assess the safety of GBCAs, and to that end, we are requiring GBCA manufacturers to conduct further studies to assess the safety of this class of contrast agents."

The FDA issued a Drug Safety Communication today about gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) to alert health care professionals and patients about gadolinium retention in the body and to provide information on how to mitigate the risk. The FDA is requiring a new class warning for all GBCAs about gadolinium remaining in the body for months or years after receiving the drug. Manufacturers of GBCAs must also conduct human and animal studies to further assess the safety of these contrast agents. The FDA is also requiring a patient medication guide providing educational information that every patient will be given before receiving a GBCA. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function and the FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

MRI scanners are diagnostic medical devices used to produce images of the body to detect problems such as cancer, infections or bleeding. GBCAs are intravenous drugs that contain gadolinium, a heavy metal, that is linked to a carrier molecule. These drugs are used to help improve visualization of internal organs, blood vessels and tissues, which helps health care professionals diagnose medical conditions.

In 2015, the FDA issued a Drug Safety Communication alerting health care professionals and patients that the agency was investigating the risk associated with gadolinium deposits in the brain following repeated use of GBCAs for MRIs. In 2017, the agency issued an updated Drug Safety Communication stating its review of available data had not identified adverse health effects from gadolinium retained in the brain after the use of GBCAs in MRIs.

Additional information for health care professionals, patients, parents and caregivers can be found in the updated Drug Safety Communication.

For more information:

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 

 

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