Australia’s medicines regulator has introduced two new safety warnings addressing mental health risks and contraceptive effectiveness for people using popular diabetes and weight-loss drugs, including Ozempic, Wegovy, Saxenda, Trulicity and Mounjaro.
The Therapeutic Goods Administration (TGA) says that while there is no proven causal link, reports of depression and suicidal thoughts among users of GLP-1 receptor agonists (GLP-1 RAs) are significant enough to warrant precaution.
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New Mental Health Warning
The TGA advises clinicians to monitor patients closely for:
- Worsening depression
- Suicidal thoughts or behaviours
- Unusual mood or behavioural changes
This class-wide advisory follows international data showing a slightly higher-than-expected rate of suicidal ideation among semaglutide users. A 2024 analysis of the World Health Organization’s adverse reaction database prompted the TGA to seek independent review, which found insufficient evidence for causality but highlighted the complex overlap between chronic endocrine illnesses and mental health.
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Australian adverse-event reports up to September include:
- 72 cases of suicidal ideation
- 6 cases of depressional suicide
- 4 suicide attempts
- 2 completed suicides
- 1 case of self-injurious ideation
More than two million semaglutide prescriptions were subsidised under the PBS in 2023–24, with additional users paying privately.
Dr Terri-Lynne South, chair of the RACGP’s obesity management special interest group, said patients with current or past depression, anxiety, or those on antidepressants may be more vulnerable. She added that rapid or significant weight loss—as seen after bariatric surgery—can also trigger mental health challenges.
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New Contraception Advisory for Mounjaro
The TGA has also issued a separate safety update for Mounjaro (tirzepatide), warning that its effect on delayed gastric emptying may reduce the absorption and effectiveness of oral contraceptive pills.
Because a link could not be ruled out, the TGA now advises patients to:
- Switch to a non-oral contraceptive, or
- Add a barrier method
for four weeks after starting Mounjaro and four weeks after each dose increase.
The regulator emphasised that no GLP-1 RA medication should be used during pregnancy.
Dr South explained that slower digestion caused by these drugs could impact how much of the contraceptive pill is absorbed, potentially lowering its effectiveness.
She stressed that these warnings are part of normal post-marketing surveillance, where rare safety signals only become visible after tens of thousands of people begin using a medication—far beyond the scale of initial clinical trials.