The Therapeutic Goods Administration (TGA), Australia’s national medicines regulator, has issued a new warning for weight loss drugs, alerting users and health professionals about possible mental health risks and other side effects associated with popular weight loss meds.
These medicines, used to treat type 2 diabetes and obesity, include Ozempic, as well as Wegovy, Saxenda, Trulicity and Mounjaro.
This warning from the TGA cannot be ignored and should be considered for awareness, as the number of people using these weight loss drugs keeps growing.
Why The New Warning Was Issued
The TGA carried out a comprehensive review after global reports flagged concerns over suicidal thoughts and self-harm in people using GLP-1 receptor agonists (GLP-1 RAs).
While the TGA found insufficient evidence to definitively confirm the drugs cause suicidal thoughts, they noted a “complex interplay” between mental illness, chronic metabolic conditions, and the psychological impact of rapid weight loss, enough to warrant caution.
What New Warning for Weight Loss Drugs Says
The new official product information for these GLP-1 drugs now includes:
- Reports of suicidal behaviour, suicidal thoughts, or self-harm among users.
- Instructions for health professionals to monitor patients for new or worsening depression, mood changes or unusual behaviour, especially in people with a history of mental illness or on antidepressant treatment.
Advert Events Reported According to the TGA’s database,
- 72 reports of suicidal ideation
- 6 reports of depressive suicide
- 4 reports of suicide attempts
- 2 reports of completed suicide
- 1 report of self-injurious thoughts or behaviour
What Are the Other Issued Warnings
In addition to the mental health warning, regulators also flagged another important issue, particularly for Mounjaro (tirzepatide).
The drug may reduce the effectiveness of oral contraceptives when first taken, or after increasing the dose.
As a precaution, users are advised to use non-oral contraception or add a barrier method for at least four weeks after starting Mounjaro and again after any dose increase.
The TGA also explicitly recommends that none of the GLP-1 medicines be used during pregnancy.
What Do These New Warnings Mean for You
For People Taking or Considering these Drugs
- If you or someone you know is using Ozempic or other GLP-1 drugs: be alert to mood changes, feelings of depression, anxiety, unusual thoughts and inform a mental-health or medical provider immediately if these arise.
- If you are using Mounjaro and also rely on oral contraceptives, discuss with your doctor about switching to a more reliable birth control method temporarily.
- Don’t panic, as the TGA says there is no proven cause-and-effect link. The new warning for weight loss drugs is precautionary, aimed at raising awareness.
For Healthcare Professionals
- Re-evaluate benefits vs risks before prescribing GLP-1 drugs, especially to patients with a past or current history of mental health issues.
- Monitor patients closely for any signs of mood changes, suicidal thoughts or other psychiatric symptoms during therapy.
- Advise patients of the contraception issue when prescribing Mounjaro and consider alternative birth control methods accordingly.
For Policymakers and Regulators
- This update underlines the importance of post-market surveillance, as some risks only emerge after millions of people begin using a drug.
- Regulators globally may need to review safety labels for GLP-1 drugs and issue similar warnings, balancing the drugs’ appeal for weight loss with mental-health risks.
- Healthcare systems should be prepared to offer support, mental-health screening and patient counselling for individuals on these therapies.
Conclusion
The new warning for weight loss drugs issued by the TGA serves as a timely reminder that even widely used, well-regarded medicines like Ozempic and Mounjaro are not without risks. The possible risks related to mental health and reduced contraceptive efficacy, though not proven causal, cannot be ignored.
For the medical and regulatory community, this update reinforces the value of vigilance, transparency, and patient-centred care. As use of GLP-1 drugs grows globally, thoughtful oversight will be crucial to protect people’s health, not just their weight.
