TGA issues two new safety alerts for GLP-1 RA products

The Therapeutic Goods Administration (TGA) has today (Monday 1 December) made updates to product warnings for GLP-1 and dual GIP/GLP-1 receptor agonists for two separate safety issues.

AP examines what pharmacists need to know.

ALERT 1: Potential risk of suicidal thoughts

The TGA has aligned product warnings for all GLP-1 RA medicines to ensure consistent information regarding the potential risk of suicidal thoughts or behaviours.

There have been growing questions about whether there’s a link between GLP-1 RAs and suicidal ideation. As of 23 September 2025, the TGA’s Database of Adverse Event Notifications (DAEN) contains the following:

• 72 reports for suicidal ideation
• 6 reports for depressional suicide
• 4 reports of suicide attempt
• 2 reports of completed suicide
• 1 report of self-injurious ideation.

The issue has been monitored by international regulations and by the TGA. In June 2025, the TGA sought expert advice on this issue from the Advisory Committee on Medicines (ACM).

Following consideration, the ACM advised that, while available evidence was not sufficient to support an association between GLP-1 RAs and suicidal or self-injurious ideation, the Australian PIs/CMIs for GLP-1 RAs contain inconsistent information about the potential risk of suicidal/self-injurious ideation.

The ACM recommended that harmonisation of these statements would be beneficial, and suggested the warning statements should reflect a class-level awareness, rather than imply a causal association.

What does the product warning say?

Psychiatric disorders

Suicidal behaviour and ideation have been reported with GLP-1 receptor agonists. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviours, and/or any unusual changes in mood or behaviour. Consider the benefits and risks for individual patients prior to initiating or continuing therapy in patients with suicidal thoughts or behaviours or have a history of suicidal attempts. 

What products are affected by this alert?

The TGA has identified all GLP-1 RA class products currently marketed in Australia are affected by the warning, including:

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

What should pharmacists do?

Pharmacists, and other health professionals caring for patients using GLP-1 RA medicines, should be alert to potential emergence or worsening of depression, suicidal thoughts or behaviours, or any unusual changes in mood or behaviour.

Patients should be advised to seek urgent care from their GP or another healthcare professional if they experience new or worsening depression, suicidal thoughts or any unusual changes in mood or behaviour. 

ALERT 2: Tirzepatide (Mounjaro) and contraception

As previously reported by AP, the use of GLP-1 RAs has been associated with increased likelihood of pregnancy. This had been speculated based on evidence that weight loss can improve fertility, as well as the possibility that GLP-1 RAs may affect absorption of the oral contraceptive pill.

The TGA has specifically investigated the potential for reduced effectiveness of oral contraception when first taking or increasing the dose of tirzepatide (Mounjaro), concluding that this association could not be ruled out.

As a precautionary measure, the TGA has overseen updated product warnings for tirzepatide. These updated warnings include further advice for patients using oral contraceptives:

Patients taking tirzepatide are advised to switch to a non-oral contraceptive or add a barrier method of contraception for 4 weeks after first taking the medicine and for 4 weeks after each increase in the dose.

Is it just tirzepatide (Mounjaro)?

While the TGA has only updated product warning for tirzepatide, the regulatory body advises that ‘none of the GLP-1 RAs should be used during pregnancy and individuals of childbearing potential are advised to use effective contraception during treatment with a GLP-1 RA’.