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Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use

Al's Comment:

   This is a preliminary report on possible problems with getting too many MRIs with Gadolinium. Most (or all) brain tumor scans use Gadolinium.  I would think that the benefit of knowing how the tumor is doing far outweighs the risk when the patient is known to have a brain tumor or has symptoms of a brain tumor.  I know many people who have had over 20 scans with Gadolinium with no apparent problems related to it.  However, it may have an impact on MRIs that are used to screen for brain tumors.  They have to figure out what the actual risk of using the Gadolinium is compared to the risk of not finding a brain tumor before symptoms appear.  That is going to be close - might tilt toward NOT doing screenings.


Posted on: 07/27/2015

MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

 

Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use

AUDIENCE: Radiology

ISSUE: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Recent publications in the medical literature have reported 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 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. FDA is 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, FDA is not requiring manufacturers to make changes to the labels of GBCA products.

BACKGROUND: 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. Available information does not identify any adverse health effects.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm456012.htm

 


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