Safety advice on particular drugs or classes of drugs
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| Canada: New safety information on injectable gadolinium-based contrast agents used in MRI scans |
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Health Canada has conducted a safety review of gadolinium-based contrast agents (GBCAs) due to growing scientific evidence that gadolinium may accumulate in the brain following multiple contrast-enhanced magnetic resonance imaging (MRI) scans.
Although no health consequences have been identified with gadolinium accumulation in the brain, Health Canada will be working with Canadian manufacturers to update the labelling of GBCAs to include this new information.
Gadolinium is a chemical element and a component of dyes used to enhance contrast and improve radiology images. GBCAs are administered by injection and used for MRI scans when needed.
After injection, gadolinium is eliminated through the kidneys (in urine) and for some of the agents also through the liver, but small amounts may stay in different parts of the body, including the brain. Gadolinium accumulation in the brain has been found in patients both with and without kidney disease.
To date, Health Canada has not received any adverse event reports related to gadolinium accumulation in the brain.
Patients and caregivers should talk to their health care professionals if they have questions about the use of GBCAs with MRIs for their individual health circumstances.
Health professionals are advised to:
• limit the use of GBCAs to situations where the contrast agent is considered necessary,
• use the lowest effective dose, and
• assess the benefits and any potential risks to individual patients before administering repeated doses of GBCAs.
Health Canada is also advising health care professionals that the available scientific evidence suggests that gadolinium accumulation in the brain is higher with the use of linear agents than with the use of macrocyclic agents, but it has occurred with both types.
Health Canada is continuing its monitoring and evaluation of the risk of gadolinium accumulation in the brain associated with the use of GBCAs and will inform Canadians again as required.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../61676a-eng.php
In Hong Kong, there are nine registered pharmaceutical products which are gadolinium contrast agents, and are prescription only medicines, including Magnevist Inj (HK-32608) containing meglumine gadopentetate, Omniscan Inj 0.5mmol/ml (HK-43493) containing gadodiamide, Gadovist Inj 1mmol/ml (HK-51750) and Gadovist Inj 1mmol/ml (Pre-filled Syringe) (HK-57330) containing gadobutrol, Primovist Pre-filled Syringe Inj 0.25mmol/ml (HK-54116) containing sodium gadoxetate, Dotarem Inj 377mg/ml (Vial) (HK-41578) and Dotarem Prefilled Syringes, 377mg/ml (HK-41579) containing meglumine gadoterate, MultiHance Inj 334mg (China) (HK-55495) and MultiHance Inj 334mg (HK-57789) containing gadobenic acid (as meglumine gadobenate).
Related news was previously issued by the US FDA, Taiwan FDA and EMA, and was posted on the Drug Office website on 28 July 2015, 12 August 2015 and 21 March 2016 respectively. So far, the Department of Health (DH) has received seven cases of adverse drug reaction (ADR) in connection with GBCAs: two cases on Omniscan, three cases on Dotarem, and two cases on Gadovist. These reported ADR cases were not related to brain deposits.
As reported previously that the US FDA will study the risk of brain deposits further to consider if change to product label is needed, and the EMA’s Pharmacovigilance Risk Assessment Committee will carry out an in-depth review of the risk of brain deposits, DH will remain vigilant on the conclusion of these reviews and any safety updates from other overseas drug regulatory authorities.
Ends/ Saturday, January 7, 2017
Issued at HKT 12:00
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