A recent safety evaluation regarding the potential risk of suicidal thoughts and self-harm associated with glucagon-like peptide-1 receptor agonists (GLP-1 RA) has been initiated by some overseas regulatory authorities. This evaluation is in response to emerging reports linked to the use of liraglutide and semaglutide for weight management. The Health Sciences Authority (HSA) is closely monitoring these international developments and collaborating with local product registrants to assess this potential safety concern. HSA will provide updates once its safety assessment is concluded.
GLP-1 RA drugs bind to the GLP-1 receptor and naturally regulate appetite and calorie intake, which in turn enhances insulin secretion and slows gastric emptying. They are prescribed for either weight management or the treatment of Type 2 diabetes mellitus (T2DM).
Ongoing assessments by the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (UK MHRA):
In July 2023, the EMA initiated a review concerning the potential risk of suicidal thoughts and self-harm in patients using Saxenda® (liraglutide), Wegovy® (semaglutide), and Ozempic® (semaglutide). This review was prompted by reports flagged by the Icelandic medicines agency. Saxenda® and Wegovy® are authorized in the European Union (EU) for weight management, while Ozempic® is indicated for T2DM but has been used off-label for weight loss. The analysis of these reports is ongoing, and it has not been confirmed whether these reports are directly linked to the drugs, the patients’ underlying conditions, or other factors. Due to the need for further investigation of this signal, the EMA expanded its review to include the entire class of GLP-1 RA drugs. The UK MHRA has also initiated its review of GLP-1 RA due to reports of suicidal and self-injurious behavior associated with the use of liraglutide and semaglutide.
Local situation:
To date, HSA has not received any local adverse event (AE) reports of suicidal thoughts or self-harm associated with GLP-1 RA. Nevertheless, HSA is closely monitoring the international developments and working with the local product registrants to assess this safety concern. HSA will provide updates when our safety assessment is completed.
HSA’s advisory and request for reporting:
Healthcare professionals are advised to use caution when prescribing GLP-1 RA drugs and report any suspected serious adverse events (AEs) related to these products to HSA’s Vigilance and Compliance Branch. Reporting can be done through the following channels:
- Adverse Drug Reactions/Drug Allergy module in the Critical Medical Information Store (CMIS) within the Electronic Medical Records (EMR) system of public healthcare institutions.
- Online reporting at https://www.hsa.gov.sg/adverse-events.
- Use of the mobile-friendly E-form for reporting.
HSA: Health Sciences Authority; EMA: European Medicines Agency; UK MHRA: UK Medicines and Healthcare Products Regulatory Agency
EU: European Union; GLP-1 RA : Glucagon-like peptide-1 receptor agonists; T2DM: Type 2 diabetes mellitus; AE: Adverse Event
CMIS: Critical Medical Information Store
Link to the HSA announcement: https://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)
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