Australia’s medicines regulator has issued a safety warning over the risk of suicidal thoughts and behaviour linked to drugs known as GLP-1 receptor agonists, including Ozempic.
The Therapeutic Goods Administration also warned that a link between GLP-1 receptor agonist medication Mounjaro (tirzepatide) and reduced effectiveness of oral contraception could not be ruled out.
Eli Lilly GLP1 medicine Mounjaro will come with a new product warning.Credit: Bloomberg
The TGA’s safety alert published on Monday said it had updated the product warnings for the class of high-profile drugs indicated for the treatment of type 2 diabetes and obesity (but known to be used for weight loss more broadly) following investigations by international regulators.
The affected drugs are:
- Ozempic (semaglutide)
- Wegovy (semaglutide)
- Saxenda (liraglutide)
- Trulicity (dulaglutide)
- Mounjaro (tirzepatide)
“Patients taking 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 alert read.
The updated wording that will appear in the product information for GLP-1 RAs.Credit: TGA
The TGA’s search of its Database of Adverse Event Notifications for GLP-1 RA medicines on September 23 retrieved 85 reports, including 72 for suicidal ideation, six for depressional suicide, four for suicide attempt, two for suicide and one of self-injurious ideation.
It’s investigation included seeking advice from an independent expert group, the Advisory Committee on Medicines, which in June reported that there was insufficient evidence of a causal link between the medicines and suicidal ideation or behaviours.
