THE Therapeutic Goods Administration (TGA) has updated product warnings for GLP-1 and dual GIP/GLP-1 receptor agonists for two separate safety issues, based on investigations by the TGA and international regulators.
The medications are used to treat type 2 diabetes and/or obesity, and in Australia comprise:
* Ozempic (semaglutide)
* Wegovy (semaglutide)
* Saxenda (liraglutide)
* Trulicity (dulaglutide)
* Mounjaro (tirzepatide)
The first warning relates to the potential risk of suicidal thoughts or behaviours.
Health professionals should monitor patients for depression, suicidal ideation or unusual changes in mood or behaviour, and should advise patients to tell them if they experience any such changes.
They are also asked to consider the benefits and risks for individual patients before initiating or continuing therapy in patients with suicidal thoughts or behaviours.
Adverse events relating to the drugs in Australia (as at 23 Sep 2025) include 85 reported incidents involving suicidal ideation and behaviour, including two completed suicides.
The TGA stressed that while there is no direct evidence supporting a causal link between GLP-1RAs and suicidal or self-injurious ideation, there is a complex interplay with mental illness and the chronic endocrine disorders the drugs are used to treat.
The second warning applies only to Mounjaro (tirzepatide) and relates to the risk of reduced effectiveness of oral contraception.
Patients are advised to use a non-oral form of contraception or add a barrier method of contraception for four weeks after first taking the medicine and for four weeks after each increase in the dose.
The TGA added that none of these drugs should be used during pregnancy and individuals of childbearing potential are advised to use effective contraception during treatment with a GLP-1 RA.
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