Consumers and health professionals are advised that the Therapeutic Goods Administration (TGA) has reviewed recent information relating to the potential for small amounts of gadolinium to be retained in the brain, following use of gadolinium-based contrast agents during magnetic resonance imaging (MRI) scans. No harmful effects of gadolinium retention in the brain have been identified at this time, but the TGA is working with sponsors of these products to update their Product Information (PI) documents to reflect the new information. Gadolinium-based contrast agents are injected into a patient’s vein to enhance the quality of MRI scans of internal organs, blood vessels and tissues. MRI scans help health professionals to diagnose medical conditions. There are two types of gadolinium-based contrast agents – linear agents and macrocyclic agents. Published studies have found that linear gadolinium-based contrast agents appear to result in greater gadolinium retention in the brain than macrocyclic agents. The TGA will continue to monitor this issue and take further action if necessary.
Information for consumers
Please be advised that this issue only relates to gadolinium-based contrast agents used in MRI scans and not to other types of scanning agents used for other imaging procedures. If you or someone you provide care for has had an MRI and you have any questions or concerns about this issue, talk to your health professional.
Information for health professionals
PI documents for gadolinium-based contrast agents have previously stated that gadolinium ‘does not cross the intact blood brain barrier’ and in some instances that gadolinium does not accumulate in normal brain tissue. There is now increasing evidence that this may occur. While no harmful effects of gadolinium retention in the brain have been identified at this time, the TGA is working with sponsors to update the PI documents and is recommending judicious use of gadolinium-based contrast agents, particularly linear agents. You are advised to limit gadolinium-based contrast agent use to circumstances where the extra information provided by the contrast agent is necessary, and in those circumstances to use the lowest effective dose and carefully consider the choice of agent. The TGA also recommends that you avoid repetitive scans using these contrast agents unless deemed clinically necessary. The Royal Australian and New Zealand College of Radiologists has also published information about this issue on its website.
TGA, 28 July 2017 ; http://www.tga.gov.au/