Updated Ozempic Warnings: Australia Investigates Mental Health and Contraception Risks

Australia’s drug regulator has issued new safety warnings for popular diabetes and weight-loss medications. The Therapeutic Goods Administration updated guidance for Ozempic and similar GLP-1 drugs in December 2025. This follows international reports of potential mental health side effects. The move impacts hundreds of thousands of Australian patients.

The warnings address potential risks of suicidal thoughts and mood changes. A separate alert advises women using the drug Mounjaro about contraception effectiveness. These updates represent a significant shift for a blockbuster class of medications.

Focus on Mental Health Signals Prompts Precaution

The TGA’s action centers on data from global adverse event reports. Signals indicated a potential link between GLP-1 drugs and suicidal ideation. According to TGA data, 72 reports of suicidal thoughts were logged by September 2025. This included several suicide attempts and a small number of deaths.

However, causality is not confirmed. The TGA and its advisory committee stated evidence remains insufficient. They noted the complex relationship between chronic illness and mental health. Patients with obesity or diabetes may have a higher baseline risk for depression.

Doctors are urged to monitor patients closely. This is especially important for those with a history of depression or anxiety. Rapid weight loss itself can also trigger mental health changes. Patients must report any new or worsening mood symptoms immediately.

New Contraception Guidance for Mounjaro Users

A second major update concerns the drug tirzepatide, sold as Mounjaro. The TGA warns it may reduce the effectiveness of oral contraceptive pills. This is linked to how GLP-1 drugs slow stomach emptying. It can affect the absorption of other medications.

Women are advised to use alternative contraception for four weeks. This applies after starting Mounjaro or increasing its dose. Non-oral or barrier methods are recommended during this period. The TGA also reinforced that GLP-1 drugs should not be used during pregnancy.

These post-market findings are common. They often emerge only after a drug is widely used by the public. The TGA’s role is to continuously evaluate safety and update information accordingly.

Balancing Breakthrough Benefits with Patient Safety

GLP-1 receptor agonists are considered a major medical advance. Drugs like Ozempic and Mounjaro help manage blood sugar and promote weight loss. Their popularity has surged globally, leading to widespread use.

The recent warnings highlight the need for ongoing vigilance. Regulators worldwide, including the U.S. FDA, are reviewing similar data. The current advice is precautionary, not a definitive condemnation. For most patients, the benefits still significantly outweigh the potential risks.

Open communication between patients and doctors is crucial. Healthcare providers must discuss these updates during consultations. Patients should not stop taking their medication without medical guidance. The goal is informed, shared decision-making.

The updated Ozempic warnings underscore a critical phase in pharmacovigilance, where real-world data shapes the safe use of revolutionary treatments. This proactive approach aims to protect patients while preserving access to effective therapies.

A quick knowledge drop for you

What are the new mental health warnings for Ozempic?

The TGA warns of potential risks of suicidal thoughts and mood changes. Patients should report any new or worsening depression or anxiety to their doctor. This is a precaution, as a direct causal link is not yet proven.

How does Mounjaro affect birth control pills?

Mounjaro may reduce the effectiveness of oral contraceptives. Women are advised to use a non-oral or barrier method for four weeks after a dose change. This is due to the drug’s effect on digestion and medication absorption.

Should I stop taking my GLP-1 medication?

No, you should not stop your medication without consulting your doctor. The benefits for managing diabetes or obesity may still be significant. Discuss any concerns with your healthcare provider to make an informed decision.

Are these side effects common?

Reported mental health side effects are considered rare. The TGA reviewed 72 reports among an estimated half-million users. However, even rare risks warrant updated safety information and patient awareness.

Is this warning for all GLP-1 drugs?

Yes, the mental health precaution applies to the entire drug class. This includes Ozempic, Wegovy, Saxenda, Trulicity, and Mounjaro. The contraception advice is specific to Mounjaro due to its unique formulation.

What should I do if I’m concerned?

Schedule an appointment with your prescribing doctor. Discuss your personal risk factors and any symptoms you may have. Do not make any changes to your treatment plan without professional medical advice.