Australia’s national medicines regulator has issued a safety warning over a class of weight-loss and diabetes drugs linked to potential mental health risks.
The Therapeutic Goods Administration (TGA) updated its product information for GLP-1 receptor agonists, a relatively new class of medicines, citing an increased risk of suicidal thoughts. The class includes semaglutide, marketed in Australia as Ozempic, as well as Wegovy, liraglutide (Saxenda), dulaglutide (Trulicity), and tirzepatide (Mounjaro).
“These medicines should prompt patients to inform their health professional if they experience new or worsening depression, suicidal thoughts, or unusual changes in mood or behaviour,” the TGA said.
Semaglutide and similar drugs are taken as weekly injections to treat type 2 diabetes but have become widely used for weight loss, gaining popularity among celebrities.
The TGA also updated warnings for tirzepatide (Mounjaro) regarding reduced effectiveness of oral contraception when starting or increasing the dose. Patients are advised to switch to non-oral contraception or use a barrier method for four weeks after starting or adjusting the dose. The TGA emphasized that no GLP-1 receptor agonists should be used during pregnancy and that individuals of childbearing potential should use effective contraception.
New Zealand Health Authorities Seek Updates
In New Zealand, the Ministry of Health confirmed that Medsafe is monitoring the Australian advisory. Approved GLP-1 medicines in New Zealand include Saxenda, Wegovy, Ozempic, Trulicity, and Victoza. Mounjaro is not approved locally.
Medsafe has investigated the potential link between GLP-1 drugs and suicidal behaviour several times, most recently last year, but found insufficient evidence to establish a causal relationship. This aligns with conclusions from international regulators, including the FDA (US), EMA (Europe), MHRA (UK), and Australia’s TGA.
A Ministry of Health spokesperson said, “While some New Zealand data sheets already mention suicidal thoughts, we have asked companies to update their information for consistency and to reflect psychiatric risks. Patients should report any changes in mood or behaviour to their healthcare provider.”
Medsafe will continue to monitor developments and advise patients accordingly.
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