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 (TGA) also warned that a link between GLP-1 receptor agonist medication Mounjaro (tirzepatide) and reduced effectiveness of oral contraception could not be ruled out.
Elly Lilly GLP1 medicine Mounjaro will come with new product warning for patientsCredit: Bloomberg
The TGA’s safety alert published on Monday said it had updated the product warnings for the class of high-profile drugs formally used to treat type 2 diabetes and obesity in Australia following investigations by international regulators.
The drugs affected 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
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.
The TGA’s investigation included seeking advice from an independent expert group, the Advisory Committee on Medicines (AMC), which in June reported that there was insufficient evidence of a causal link between the medicines and suicidal ideation or behaviours.