TGA issues fresh warning for Ozempic and other high-profile drugs

Monday, 1 December 2025 19:36

Australia's drugs regulator has new advice on the risk of suicidal ideas and contraception issues.

Australia's drugs regulator has issued a fresh warning for users of high-profile injectable diabetes and weight-loss drugs such as Ozempic.

The Therapeutic Goods Administration today updated its advice for the whole class of GLP-1 receptor agonists with warnings about the potential for suicidal thoughts, as well as an increased contraception warning for one popular brand.

The updated self-harm advice followed international signs of "potential risk of suicidal thoughts or behaviours".

The TGA said it consulted with the Advisory Committee on Medicines, which didn't find enough evidence to support a causal link but noted "complex interplay between mental illness and chronic endocrine disorders" for which the drugs may be prescribed.

It also highlighted the "potential relationship between weight loss and suicidal/self-injurious ideation".

"Patients taking any of these medicines should tell their health professional if they experience new or worsening depression, suicidal thoughts or any unusual changes in mood or behaviour," the TGA recommended.

The warning covers Ozempic (semaglutide), Wegovy (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide) and Mounjaro (tirzepatide).

The TGA also couldn't rule out a link between Mounjaro and reduced effectiveness of oral contraception.

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

None of the class of drugs should be used during pregnancy.

The injectables, first used to treat type 2 diabetes, have become wildly popular since their appetite suppression properties were discovered.

They're used to treat obesity, as well as by many for general weight loss.

The World Health Organisation on Monday issued its first guideline on the use of GLP-1 therapies for obesity, conditionally recommending them as part of long-term treatment for the condition.

But researchers have also raised several health concerns, such as arthritis and stomach issues, while noting the potential for health benefits for overweight people stemming from weight loss.

Potential long-term side effects of the new drugs are yet to be fully understood.

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