其 他 安 全 警 示
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| Canada: Summary Safety Review: Glucagon-like Peptide 1 Receptor Agonists (GLP-1 RAs) (dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide) - Assessing the potential risks of suicide, self-harm and suicidal/self-harm ideation (English only) |
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Health Canada announces that it reviewed the potential risks of suicide, self-harm and suicidal/self-harm ideation with the use of GLP-1 RAs. The safety review was triggered by case reports of suicidal thoughts and self-harm submitted to the European Medicines Agency (EMA).
Glucagon-like peptide 1 receptor agonists are a class of prescription drugs authorized for sale in Canada for adults with type 2 diabetes [Ozempic/Rybelsus (semaglutide), Victoza (liraglutide), Trulicity (dulaglutide), Xultophy (insulin degludec and liraglutide) and Soliqua (insulin glargine and lixisenatide)], or for chronic weight management in adults and adolescents who are obese or overweight [Wegovy (semaglutide) and Saxenda (liraglutide)].
Health Canada reviewed the available information provided by manufacturers, and from searches of the Canada Vigilance database, the World Health Organization’s adverse drug reaction database and the scientific literature. Health Canada reviewed 15 cases (3 Canadian and 12 international) of suicide, self-harm and suicidal/self-harm ideation in patients using GLP-1 RAs, including 2 from the published literature. Of the 15 cases, 12 (3 Canadian) were found to be possibly linked to the use of GLP-1 RAs and 3 could not be assessed due to missing clinical information.
A definitive link could not be confirmed due to insufficient information about possible confounders (other factors that may have contributed to the occurrence of suicide, self-harm and suicidal/self-harm ideation), such as pre-existing mental health problems, family history, life stressors, social and environmental factors, and use of other medications that has labelling related to suicidality.
Health Canada also reviewed clinical trial data from the manufacturers, and real-world data from published and unpublished sources. Overall, the evidence from these studies does not support a link between GLP-1 RAs and the risks of suicide, self-harm and suicide/self-harm ideation in patients with type 2 diabetes. However, in the subgroup of patients with obesity (with or without type 2 diabetes), the evidence was not as clear. Additional information is needed to determine if there is a link between GLP-1 RAs and suicide, self-harm, and suicide/self-harm ideation in patients with obesity (with or without type 2 diabetes).
Health Canada’s review did not find evidence to support a link between GLP-1 RAs and the risks of suicide, self-harm and suicidal/self-harm ideation in patients with type 2 diabetes. There was not enough information to determine if there is a link in patients with obesity. Health Canada published a Health Product InfoWatch communication in December 2024 to share information about the review with healthcare professionals. Health Canada will continue to monitor the safety of GLP-1 RAs.
Please refer to the following website in Health Canada for details:
http://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090
In Hong Kong, there are registered pharmaceutical products containing exenatide (1 product), lixisenatide (2 products), liraglutide (5 products), dulaglutide (4 products), and semaglutide (11 products). All products are prescription-only medicines. So far, the Department of Health (DH) has received adverse drug reactions with regard to exenatide (2 cases), lixisenatide (1 case), liraglutide (1 case), dulaglutide (5 cases), and semaglutide (10 cases), but these cases were not related to suicide or self-harm ideation. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 12 Jul 2023, with the latest update posted on 5 Sep 2024. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Friday, Mar 28, 2025
Issued at HKT 17:45
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