The Australian Therapeutic Goods Administration (TGA) has updated its product warnings on the class of weight loss and diabetes drugs that includes Ozempic and Mounjaro.
The safety alert issued by the regulator on Monday details links to two separate safety issues; the potential risk of suicidal thoughts, and reduced effectiveness of oral contraception.
It relates to GLP-1 and dual GIP/GLP-1 receptor agonists which are primarily prescribed to manage type 2 diabetes and obesity, and are marketed in Australia as Ozempic (semaglutide) Wegovy (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide) and Mounjaro (tirzepatide).
The TGA advised that patients taking any of those medications should “tell their health professional if they experience new or worsening depression, suicidal thoughts or any unusual changes in mood or behaviour.”
The TGA’s Database of Adverse Event Notifications for this class of medications includes 72 reports for suicidal ideation for the class of medications, and 6 reports of attempted or completed suicide, as of 23 September 2025.
After conducting a comprehensive investigation, the TGA stated that there isn’t enough evidence to support a “causal association” between the drugs and suicidal or self-harming behaviours. However, the updated warning reflects a “class level awareness” about potential risks.
The Advisory Committee on Medicines, whose advice was sought by the TGA as part of the investigation, noted that there is a complex relationship between mental illness and the disorders that this class of drugs is used to treat.
It also outlined a potential relationship between weight loss and suicidal or self-injurious thoughts.
A separate warning was issued in relation to Mounjaro (tirzepatide) and contraception, recommending that patients taking the drug should switch to a non-oral contraceptive or use an additional barrier method for contraception in the four weeks after they begin taking the medication, and for four weeks after each increase in dose.
The TGA stressed that none of the GLP-1 RA medications should be used during pregnancy, and that effective contraception should be used by patients of child-bearing age.
