Other safety alerts
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| Singapore: HSA is assessing the potential risk of suicidal thoughts and self-harm with glucagon-like peptide-1 receptor agonists (GLP-1 RA) |
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Health Sciences Authority (HSA) announces that a safety review on the potential risk of suicidal thoughts and self-harm with glucagon-like peptide-1 receptor agonists (GLP-1 RA) was recently initiated by some overseas regulatory authorities due to emerging reports associated with the use of liraglutide and semaglutide for weight management. HSA is monitoring the international developments closely and working with the local product registrants to assess this potential safety concern. HSA will provide updates when its safety assessment is completed.
GLP-1 RA bind to the GLP-1 receptor and physiologically regulate appetite and calorie intake, thereby enhancing insulin secretion and slowing gastric emptying. They are indicated either for weight management or Type 2 diabetes mellitus (T2DM).
In Jul 2023, the European Medicines Agency (EMA) initiated its review on the potential risk of suicidal thoughts and self-harm in patients taking Saxenda® (liraglutide), Wegovy® (semaglutide) and Ozempic® (semaglutide), due to reports flagged by the Icelandic medicines agency. Saxenda® and Wegovy® are authorised in the European Union for weight management, whereas Ozempic® is indicated for T2DM but has been used off-label for weight loss. The analysis of the reports is ongoing, and it has not been confirmed whether these reports are linked to the drugs, the patients’ underlying conditions or other factors. As further investigation of this signal was warranted, the EMA subsequently extended its review to include the entire class of GLP-1 RA. The United Kingdom Medicines and Healthcare Products Regulatory Agency has also initiated its review on GLP-1 RA due to domestic reports received on suicidal and self-injurious behaviour with the use of liraglutide and semaglutide.
There are currently eight GLP-1 RA products registered locally in Singapore: Saxenda® (liraglutide), Wegovy® (semaglutide), Trulicity® (dulaglutide), Victoza® (liraglutide), Soliqua® (lixisenatide with insulin glargine), Rybelsus® (semaglutide), Ozempic® (semaglutide) and Mounjaro® (tirzepatide). To date, HSA has not received any local adverse event (AE) reports of suicidal thoughts or self-harm associated with GLP-1 RA. Healthcare professionals are advised to exercise caution in the use of GLP-1 RA and report suspected serious AEs related to these products to the Vigilance and Compliance Branch of HSA.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/safety-alert/hsa-is-assessing-the-potential-risk-of-suicidal-thoughts-and-self-harm-with-glucagon-like-peptide-1-receptor-agonists-(glp-1-ra)
In Hong Kong, there are registered pharmaceutical products containing dulaglutide (4 products), exenatide (1 product), liraglutide (3 products), lixisenatide (2 products) and semaglutide (6 products). All products are prescription-only medicines. There is no registered pharmaceutical product containing tirzepatide. So far, the Department of Health (DH) has received adverse drug reaction related to dulaglutide (5 cases), exenatide (2 cases), liraglutide (1 case), lixisenatide (1 case) and semaglutide (3 cases), but these cases were not related to suicidal thoughts or self-injury. Related news was previously issued by European Medicines Agency, and was posted on the Drug Office website on 12 Jul 2023. As the safety review is ongoing, the DH will remain vigilant on the conclusion of the review and safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Friday, Sep 22, 2023
Issued at HKT 15:00
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