HSA is assessing the potential risk of suicidal thoughts and self-harm with glucagon-like peptide-1 receptor agonists (GLP-1 RA)
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 our 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).
Ongoing reviews by European Medicine Agency (EMA) and UK Medicines and Healthcare Products Regulatory Agency (UK MHRA)
In July 2023, the 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.1 Saxenda® and Wegovy® are authorised in the European Union (EU) 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 UK MHRA 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.
Local situation
There are currently eight GLP-1 RA products registered locally in Singapore (Table 1).
Table 1. GLP-1 RA products registered in Singapore
|
Active ingredient
|
Brand
|
Product registrant
|
Indication
|
|
Liraglutide
|
Saxenda®
|
Novo Nordisk Pharma (Singapore) Pte Ltd
|
Adjunct to a reduced-calorie diet and increased physical activity for weight management in obese or overweight patients
|
|
Semaglutide
|
Wegovy®
|
Novo Nordisk Pharma (Singapore) Pte Ltd
|
|
Dulaglutide
|
Trulicity®
|
DKSH Singapore Pte Ltd
|
Adjunct to diet and exercise to improve glycaemic control in patients with T2DM
|
|
Liraglutide
|
Victoza®
|
Novo Nordisk Pharma (Singapore) Pte Ltd
|
|
Lixisenatide with insulin glargine
|
Soliqua®
|
Sanofi-Aventis Singapore Pte Ltd
|
|
Semaglutide
|
Rybelsus®
|
Novo Nordisk Pharma (Singapore) Pte Ltd
|
|
Semaglutide
|
Ozempic®
|
Novo Nordisk Pharma (Singapore) Pte Ltd
|
|
Tirzepatide
|
Mounjaro®
|
DKSH Singapore Pte Ltd
|
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 call for reporting
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. The following reporting channels may be used:
References
- https://www.ema.europa.eu/en/news/ema-statement-ongoing-review-glp-1-receptor-agonists
Healthcare professional, Industry member, Therapeutic Products
Published:
Safety Alerts