TGA Warns: Mental Health & Contraception Risks with GLP-1 Drugs

1 December 2025 – In a significant move, Australia’s Therapeutic Goods Administration (TGA) has published updated safety warnings for the widely used class of GLP-1 receptor agonist (GLP-1) medications, addressing two separate but critical safety concerns. The advisory covers high-profile drugs such as Ozempic (semaglutide), Wegovy (semaglutide), Saxenda (liraglutide), and Mounjaro (tirzepatide), which are prescribed for type 2 diabetes and chronic weight management.

The agency has mandated new, aligned product warnings for the entire drug class regarding a potential risk of suicidal thoughts and has issued a specific, precautionary contraception update for the drug Mounjaro.

1. Class-Wide Warning: Potential Risk of Suicidal Thoughts

In an effort to ensure consistent safety information, the TGA has aligned product warnings across all GLP-1 medicines. This follows investigations by the TGA and other international regulators into reports of suicidal ideation and behavior. The updated guidance highlights a potential risk that patients may experience new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior while taking these medications.

Advice for Patients:

Patients currently using any GLP-1drug are strongly advised to monitor their mental health and to inform their healthcare professional immediately if they experience any such symptoms. They should not stop their medication without first consulting their doctor.

2. Specific Contraception Warning for Mounjaro (Tirzepatide)

A separate TGA investigation focused on Mounjaro (tirzepatide) has resulted in a new, precautionary contraception warning. The agency concluded that a potential reduction in the effectiveness of oral contraceptives (birth control pills) “could not be ruled out,” particularly when a patient first starts treatment or increases their dose.

New Precautionary Advice:

As a result, the Product Information and Consumer Medicines Information for Mounjaro have been updated. The TGA advises:

• Patients taking oral contraceptives should switch to a non-oral method (such as an implant or IUD) or add a barrier method (like condoms).

• This additional precaution is recommended for 4 weeks after starting Mounjaro and for 4 weeks after each increase in dosage.

Pregnancy Reminder:

The TGA reiterates that no GLP-1medicine is recommended for use during pregnancy. Individuals of childbearing potential are advised to use effective contraception throughout their treatment with any drug in this class.

Key Takeaways and Actions Required

The TGA’s dual update underscores the importance of continuous post-market surveillance for newer medication classes. For the public and healthcare providers, the key actions are:

1. Mental Health Vigilance: All patients on GLP-1 RAs should be aware of the potential for mood-related side effects and report any concerns promptly.

2. Contraception Review: Patients prescribed Mounjaro who use oral contraceptives must discuss this new guidance with their doctor to ensure continued contraceptive efficacy.

3. Professional Guidance: Healthcare professionals are urged to incorporate these updated warnings into their patient consultations and prescribing practices.

Patients are reminded not to discontinue their medication without medical supervision, as the benefits for managing diabetes or obesity may still outweigh the risks for most individuals. The TGA states it will continue to monitor the safety of these medicines and take further regulatory action if needed.

Related Articles:
1. GLP-1 Medications: New Drugs for Weight Loss and Diabetes
2. Ozempic, Wegovy & Mounjaro: GLP-1 Drugs for Weight Loss & Diabetes

Sources:
Therapeutic Goods Administration (TGA)
https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/product-warnings-updated-glp-1-ra-class

https://www.tga.gov.au/news/safety-updates/glp-1-ras-warnings-aligned-over-potential-risk-suicidal-thoughts-or-behaviours