Australia: The Therapeutic Goods Administration (TGA) has added new safety warnings for widely used diabetes and weight loss medications, including Ozempic, Wegovy, Saxenda, Trulicity, and Mounjaro, with concerns about mental health and contraceptive effectiveness.
While there is no confirmed causal link, experts say the potential risks are significant enough to warrant caution. The warnings focus on suicidal thoughts, mood changes, and reduced effectiveness of oral contraceptives for certain patients.
The TGA highlighted that suicidal behaviour and ideation have been reported with GLP-1 receptor agonists (GLP-1 RAs), a class of relatively new medicines often prescribed for diabetes and obesity. Doctors are advised to monitor patients closely for signs of depression, suicidal thoughts, or unusual changes in behaviour.
A 2024 study analysing the World Health Organisation’s global adverse reaction database found that reports of suicidal thoughts were slightly higher than expected for semaglutide, even when compared with other diabetes drugs.
Following this, the TGA consulted its Advisory Committee on Medicines, which concluded there was insufficient evidence to prove causality but acknowledged a complex relationship between mental illness and chronic endocrine conditions.
TGA records show that up to September, there were 72 reports of suicidal ideation, six reports of depression-related suicide, four suicide attempts, two completed suicides, and one report of self-injurious ideation among GLP-1 RA users. More than two million semaglutide prescriptions were recorded under Australia’s Pharmaceutical Benefits Scheme in 2023–24, with additional users outside the scheme.
Dr. Terri-Lynne South, chair of the Royal Australian College of General Practitioners’ obesity management interest group, said patients with a history of depression or anxiety, or those taking antidepressants, may be more vulnerable to mental health impacts. Rapid or significant weight loss, as seen in bariatric surgery, can also trigger psychological distress.
In a separate warning, the TGA has advised that Mounjaro may reduce the effectiveness of oral contraceptives, particularly when first starting or increasing the dose. Patients are now recommended to switch to non-oral contraceptives or use a barrier method for four weeks after starting or increasing the dose. The TGA also reiterated that GLP-1 RA medications should not be used during pregnancy.
South explained that Mounjaro delays gastric emptying, which can affect the absorption of oral contraceptives and potentially reduce their effectiveness. She emphasised that these warnings are part of routine post-market surveillance, noting that some effects only become evident once the drugs are widely used.
TOP PICKS | Kyrgyzstan votes in snap election expected to cement Japarov’s power
