Australian health authorities have issued a crucial safety alert for a popular class of diabetes and weight-loss medications, warning of potential mental health risks including suicidal thoughts and depression. The Therapeutic Goods Administration (TGA) released the advisory on November 30, 2025, highlighting concerns linked to GLP-1 receptor agonists such as semaglutide (sold as Ozempic and Wegovy).
The Safety Alert and Its Scope
The TGA's warning extends to several widely used medications: semaglutide (Ozempic, Wegovy), liraglutide (Saxenda), dulaglutide (Trulicity), and tirzepatide (Mounjaro). Collectively, these drugs are used by approximately 500,000 Australians for managing type 2 diabetes and controlling weight. While the TGA states there is no proven causal link, the decision to standardise product labels came after a review of adverse event reports up to September 2025.
This review included 72 reports of suicidal ideation, 6 suicides linked to depression, 4 suicide attempts, and 2 completed suicides. The action aligns with similar investigations initiated by global regulators like the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the World Health Organization (WHO), which noted a higher number of suicidal thought reports for semaglutide compared to other diabetes drugs.
Understanding the Potential Risks and Conflicting Evidence
Dr. Terri-Lynne South from the Royal Australian College of General Practitioners (RACGP) explains that individuals with a history of depression, anxiety, or those on antidepressants may face a higher risk of adverse effects. She draws a parallel between the psychological impact of rapid weight loss from these drugs and the known mental health changes following bariatric surgery.
The mechanism behind these potential mood changes is believed to be related to how GLP-1 drugs interact with the brain's dopamine reward systems. Furthermore, common physical side effects like nausea and fatigue can exacerbate or trigger anxiety symptoms in patients.
However, evidence remains conflicted. A study published in JAMA evaluating four clinical trials of semaglutide found that psychiatric adverse events occurred at rates comparable to a placebo in participants without pre-existing conditions. Other research suggests that the significant weight loss achieved with these medications can actually lead to improved mental health outcomes for many obese patients by reducing symptoms of depression and anxiety.
Conversely, research in Scientific Reports indicated that GLP-1 medications might increase depression, anxiety, and suicidal thoughts via their effects on dopamine. Given this conflicting data, the TGA maintains a cautious stance and has called for additional studies.
What This Means for Patients in India and Globally
The TGA now mandates healthcare providers to conduct a thorough assessment of a patient's mental health history before initiating treatment with any GLP-1 receptor agonist. For patients currently on these drugs, vigilance is key.
Patients are advised to:
- Immediately inform their doctor if they experience any mood changes, new or worsening depression, or thoughts of self-harm.
- Stop the medication and seek urgent medical assistance if suicidal thoughts develop.
- Undergo a complete risk assessment and commit to ongoing monitoring if they have pre-existing mental health conditions.
- Combine medication with holistic lifestyle programs involving exercise, diet, and therapy for long-term success.
- Consider annual mental health evaluations while on this treatment.
The popularity of these drugs has surged, with the Australian government subsidising over 2 million prescriptions for semaglutide in the 2023-24 period alone, partly driven by social media promotion for weight loss. The TGA also issued a separate warning for Mounjaro (tirzepatide) regarding decreased effectiveness of oral contraceptives when dosages are changed.
This alert underscores a critical message: while GLP-1 drugs offer substantial benefits for physical health, a proactive approach to monitoring mental wellbeing is now an essential part of the treatment journey. Patients and doctors must work together to balance the significant benefits against potential risks.
