Popular weight loss and diabetes medications, including Ozempic and Mounjaro, have been officially linked to an increased risk of suicidal thoughts and self-harming behaviours by Australia's medical regulator.
Safety Alert Issued After 85 Adverse Reports
On Monday, the Therapeutic Goods Administration (TGA) issued a significant safety warning regarding a class of drugs known as GLP-1 receptor agonists (GLP-1 RAs). The alert followed a review of its adverse event database, which on September 23 retrieved 85 separate reports connecting these medicines to a decline in mental health.
The concerning data included 72 reports of suicidal ideation, six for depression linked to suicide, four for suicide attempts, two for suicide, and one for self-injurious thoughts. The drugs named in the reports were Ozempic (semaglutide), Wegovy (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide), and Mounjaro (tirzepatide).
Expert Investigation Reverses Earlier Stance
The disturbing findings triggered a new investigation by the independent Advisory Committee on Medicines. This marked a shift from the committee's position in June, when it concluded there was insufficient evidence to connect GLP-1 medications to suicidal thoughts or actions.
The latest investigation found a 'complex interplay between mental illness and chronic endocrine disorders', which these drugs treat. It also noted a 'potential relationship between weight loss and suicidal or self-harm ideation'.
The TGA now explicitly advises that patients taking these medicines should inform their healthcare professional if they experience new or worsening depression, suicidal thoughts, or any unusual changes in mood or behaviour.
Updated Warnings and Contraception Advice
In response, the TGA has updated its official advice for all GLP-1 RAs to include a warning about suicidal ideation. Furthermore, the regulator has issued specific new guidance for the drug Mounjaro (tirzepatide) concerning contraception.
Following international anecdotal reports of so-called 'Ozempic babies', a TGA investigation found a link between tirzepatide and reduced effectiveness of oral contraception 'could not be ruled out'. One 2024 study indicated the drug could double the time it takes for a key contraceptive hormone to be fully absorbed.
Consequently, the TGA now advises Mounjaro patients to use non-oral contraception for the first four weeks of treatment and for four weeks after any dose increase. It reiterated that none of the GLP-1 RAs should be used during pregnancy.
The TGA's advisory committee also recommended that safety information for GLP-1 RAs be standardised, as existing warnings have been inconsistent. The owners of Ozempic and Mounjaro have been contacted for comment.
