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Consumers and health professionals are advised that the 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 (see below for references).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 (Table 1).
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.
| Product name | Sponsor | Agent type |
|---|---|---|
| Dotarem - gadoteric acid | Apollo Imaging Solutions Pty Ltd | Macrocyclic |
| Gadovist - gadobutrol | Bayer Australia Ltd | Macrocyclic |
| Prohance - gadoteridol | Bracco Pty Ltd | Macrocyclic |
| Magnevist - gadopentetate dimeglumine | Bayer Australia Ltd | Linear |
| Multihance - gadobenate dimeglumine | Bracco Pty Ltd | Linear |
| Omniscan - gadodiamide | GE Healthcare Australia Pty Ltd | Linear |
| Optimark - gadoversetamide | Guerbet Australia Pty Ltd | Linear |
| Primovist - disodium gadoxetate | Bayer Australia Ltd | Linear |
References
- Cao, Y, Huang, DQ, Shih, G, & Prince, MR (2016). Signal Change in the Dentate Nucleus on T1-Weighted MR Images After Multiple Administrations of Gadopentetate Dimeglumine Versus Gadobutrol. AJR Am J Roentgenol, 206, 414-9.
- Flood TF, Stence NV, Maloney JA, Mirsky DM. (2016) Pediatric Brain: Repeated Exposure to Linear Gadolinium-based Contrast Material Is Associated with Increased Signal Intensity at Unenhanced T1-weighted MR Imaging. Radiology. Jul 28:160356.
- Kanda, T, Ishii, K, Kawaguchi, H, Kitajima, K, & Takenaka, D (2014). High signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images: relationship with increasing cumulative dose of a Gd-based contrast material. Radiology, 270, 834-41.
- Kanda T, Fukusato T, Matsuda M, Toyoda K, Oba H, Kotoku J, et al. (2015a). Gd-based Contrast Agent Accumulates in the Brain Even in Subjects without Severe Renal Dysfunction: Evaluation of Autopsy Brain Specimens with Inductively Coupled Plasma Mass Spectroscopy. Radiology 2015 Jul;276(1):228-232.
- Kanda, T, Osawa, M, Oba, H, Toyoda, K, Kotoku, J, Haruyama, T, Takeshita, K, & Furui, S (2015b). High Signal Intensity in Dentate Nucleus on Unenhanced T1-weighted MR Images: Association with Linear versus Macrocyclic Gd Chelate Administration. Radiology, 275, 803-9.
- Mcdonald, RJ, Mcdonald, JS, Kallmes, DF, Jentoft, ME, Murray, DL, Thielen, KR, Williamson, EE, & Eckel, LJ (2015). Intracranial Gd Deposition after Contrast-enhanced MR Imaging. Radiology, 275, 772-82.
- Murata N, Gonzalez-Cuyar LF, Murata K, Figner C, Dills R, Hippe D, & Maravilla KR (2016). Macrocyclic and Other Non-Group 1 Gd Contrast Agents Deposit Low Levels of Gd in Brain and Bone Tissue: Preliminary Results From 9 Patients With Normal Renal Function. Invest Radiol. 2016 Feb 8.
- Radbruch, A, Weberling, LD, Kieslich, PJ, Eidel, O, Burth, S, Kickingereder, P, Heiland, S, Wick, W, Schlemmer, HP, & Bendszus, M (2015a). Gd retention in the dentate nucleus and globus pallidus is dependent on the class of contrast agent. Radiology, 275, 783-791.
- Ramalho, J, Semelka, RC, Alobaidy, M, Ramalho, M, Nunes, RH, & Castillo, M (2016). Signal intensity change on unenhanced T1-weighted images in dentate nucleus following gadobenate dimeglumine in patients with and without previous multiple administrations of gadodiamide. Eur Radiol. 2016 Feb 24.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.