其 他 安 全 警 示
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| Canada: Summary Safety Review: Iodinated contrast Medium: Assessing the potential risk of hypothyroidism in children under 3 years of age (English only) |
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Health Canada announces that it reviewed the potential risk of transient (temporary) or permanent hypothyroidism with the use of iodinated contrast medium (ICM) products in children and adults in 2017. The Department concluded that there is a risk of rare cases of hypothyroidism with the use of these products in certain patients, mostly infants (less than 1 year of age). The Canadian product monographs (CPMs) of all reviewed ICM products were updated to include this risk.
Since 2017, new studies evaluating this risk have been published. In 2023, Health Canada reviewed these new studies and the earlier ones published in the medical literature that assessed the potential risk of hypothyroidism in children under 3 years of age who were exposed to ICM products. The safety review was triggered by a labelling update in the U.S. for children 3 years of age or younger. Hypothyroidism in young children may be harmful for neurological (brain) and cognitive (how children think and understand) development.
Health Canada reviewed information from searches of the Canada Vigilance Database, international databases, and the scientific literature. At the time of the review, Health Canada had not received any Canadian reports of hypothyroidism related to the use of ICM products in children.
Health Canada reviewed 18 articles published in the scientific literature, including 2 studies published since the 2017 review that were conducted in a larger population of children. Overall, the evidence reviewed was limited, but suggested an association between hypothyroidism and ICM exposure in children under 3 years of age. Most cases in these studies reported that hypothyroidism was temporary and did not require treatment.
The rate of hypothyroidism was found to be higher in children under 3 years of age with the following risk factors: very low birth weight, prematurity, and the presence of cardiac and other conditions, such as admission to intensive care units.
Health Canada's review of the available information concluded that there is a potential risk of hypothyroidism with the use of ICM products in children under 3 years of age. Younger age, very low birth weight, prematurity, and the presence of cardiac or other conditions, such as admission to intensive care units, are associated with a higher risk of hypothyroidism after exposure to ICM products. Despite the limited available evidence, the seriousness and life-long effects on the cognitive and neurological development of children under 3 years of age warrant a precautionary approach.
Health Canada will work with the manufacturers to update the CPM of all ICM products to provide additional information about the risk of hypothyroidism in children under 3 years of age and recommend monitoring of young children based on their risk factors. Health Canada will also inform healthcare professionals about this update through a Health Product InfoWatch communication.
Please refer to the following website in Health Canada for details:
http://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1714657204971
In Hong Kong, there are registered pharmaceutical products which are iodine-containing contrast agents containing iodixanol (2 products), iopromide (2 products), ioversol (4 products), iohexol (2 products), iodised oil (1 product), iopamidol (2 products) and mixture of meglumine amidotrizoate and sodium amidotrizoate (1 product). There is no registered pharmaceutical product containing iothalamate meglumine. So far, the Department of Health (DH) has received adverse drug reaction with regard to iodixanol (3 cases), iopromide (48 cases), iohexol (2 cases), iodised oil (2 cases), iopamidol (6 cases), but these cases were not related to hypothyroidism. The DH has not received any case of adverse drug reaction with regard to ioversol and mixture of meglumine amidotrizoate and sodium amidotrizoate.
Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 18 Nov 2015, with the latest update posted on 25 Apr 2023. Letters to inform local healthcare professionals were issued by the DH on 18 Nov 2015 and 31 Mar 2022. In Apr 2016, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided that the sales pack labels and/or package inserts of iodine-containing contrast agents should include safety warnings on the risk of hypothyroidism. As previously reported, the matter will be further discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Jun 28, 2024
Issued at HKT 17:30
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