Glucagon-like peptide-1 receptor agonists: warnings aligned over potential risk of suicidal thoughts or behaviours

Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 1 December 2025.

 

Summary

Product warnings across the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class of medicines have been aligned to ensure consistent information regarding the potential risk of suicidal thoughts or behaviours.

The GLP-1 RA prescription medicines are used primarily to manage type 2 diabetes mellitus and obesity.

The updates follow investigations by the Therapeutic Goods Administration (TGA) and other international regulators.

The TGA sought advice from the Advisory Committee on Medicines (ACM), an independent body providing advice on medicines to the TGA and government, who found that the evidence available was not sufficient to support an association between GLP-1 RAs and suicidal or self-harming behaviours. However, the ACM noted that the Product Information (PI) and Consumer Medicine Information (CMI) documents across the class were inconsistent and should be harmonised.

The ACM stressed that updates should not imply a causal association but reflect a class-level awareness.

The GLP-1 RAs currently marketed in Australia are:

• semaglutide (Ozempic, Wegovy)
• liraglutide (Saxenda)
• dulaglutide (Trulicity)
• tirzepatide* (Mounjaro)

What health professionals should do

Health professionals should:

• monitor for the emergence or worsening of depression, suicidal thoughts or behaviours, or any unusual changes in mood or behaviour
• consider the benefits and risks for individual patients before initiating or continuing therapy in patients with suicidal thoughts or behaviours
• advise patients to tell their health professional if they experience new or worsening depression, suicidal thoughts or any unusual changes in mood or behaviour.

^* Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA.

See the full article on the TGA website.