Today, July 27, 2015, the FDA issued its initial Safety Announcement concerning possible safety risks caused by brain deposits of Gadolinium following repeated use of Gadolinium-based contrast agents for MRIs. A link to the document on the FDA website is provided below. The following is the FDA’s Safety Announcement:
FDA Drug Safety Communication: FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI)
The U.S. Food and Drug Administration (FDA) is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). MRIs help detect abnormalities of body organs, blood vessels, and other tissues. Recent publications in the medical literature have reported that deposits of GBCAs (See Table 1) remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration.1-21 It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects.
FDA, including its National Center for Toxicological Research (NCTR), will study this possible safety risk further. We are working with the research community and industry to understand the mechanism of gadolinium retention and to determine if there are any potential adverse health effects. Based on the need for additional information, at this time, we are not requiring manufacturers to make changes to the labels of GBCA products.
To reduce the potential for gadolinium accumulation, health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary. Health care professionals are also urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols.
Patients, parents, and caregivers should talk to their health care professionals if they have any questions about the use of GBCAs with MRIs. This issue affects only GBCAs; it does not apply to other types of scanning agents used for other imaging procedures, such as those that are iodine-based or radioisotopes.
After being administered, GBCAs are mostly eliminated from the body through the kidneys. However, trace amounts of gadolinium may stay in the body long-term. Recent studies conducted in people and animals have confirmed that gadolinium can remain in the brain, even in individuals with normal kidney function.1-21 Available information does not identify any adverse health effects.
We urge health care professionals, patients, and parents/caregivers to report possible side effects involving GBCAs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
The list of approved GBCAs (Table 1), Data Summary, and References included with this FDA Communication can be found here: http://www.fda.gov/Drugs/DrugSafety/ucm455386.htm
Patients who believe they have been adversely affected by an MRI contrast agent should report their experience to the FDA using its MedWatch Adverse Event Reporting System which can be found here: http://www.fda.gov/Safety/MedWatch/default.htm