Evaluating Risk of Repeated Gadolinium Use
The Food and Drug Administration (FDA) is evaluating the risk of gadolinium based contrast agents (GBCAs) leaving brain deposits with repeated use. GBCAs are used to help detect abnormalities in organs, tissues and blood vessels in Magnetic Resonance Imaging (MRI) scans. Recent studies and publications have reported deposits remain in the brain of patients that have received four or more MRI scans using GBCAs years after receiving the last dose.
The FDA and the National Center for Toxicological Research (NCTR) will study the possible safety risk of these deposits because it is currently unknown whether these Gadolinium deposits are potentially harmful. Manufacturers of GBCAs are not currently being required to make changes to these products or their labels until further information is gathered.
Health professionals are being encouraged to reassess the necessity of multiple GBCA MRIs in treatment protocols and should consider limiting GCBA use to clinical procedures or circumstances that require additional information provided by use of these contrast agents.
The issue only applies to GBCAs not to other scanning agents. The FDA is urging healthcare professionals, patients, parents and caregivers to report possible side effects relating to GBCA use to the FDA Medwatch program.
For additional information from the FDA announcement:
SAFETY ANNOUNCEMENT
For more information on the related studies:
STUDY #1
STUDY #2
STUDY #3
