TGA issues GLP-1 RA class-wide safety update

The Therapeutic Goods Administration (TGA) has updated its product warnings for GLP-1 RAs, saying they have potential to cause a rare but severe eye condition.
 
In a safety update published on Thursday, the regulator made a class-wide warning covering all GLP-1 RA medicines currently on sale in Australia.
 
These include semaglutide (sold as Ozempic and Wegovy), tirzepatide (Mounjaro), liraglutide (Saxenda) and dulaglutide (Trulicity).
 
The TGA described the eye disorder, non-arteritic anterior ischaemic optic neuropathy (NAION), as ‘a rare but serious condition that may result in permanent visual impairment, including blindness and no treatment has been shown to improve visual acuity outcomes’.
 
It is now urging health professionals to be aware of the warnings and advise patients to seek urgent ophthalmological examination if affected by sudden vision loss, including partial loss of vision.
 
The update follows previous concerns of a possible link between taking the medications and the condition.
 
Dr Terri-Lynne South, Chair of RACGP Specific Interests Obesity, said GPs should expect an increase in inquiries following the update.
 
‘It’s really important for GP prescribers to understand that there are a number of risk factors for the NAION, which includes reasons that people might be on the medication,’ she told newsGP.
 
‘For example, type 2 diabetes is a risk factor for this eye condition, so is high blood pressure, so is obstructive sleep apnoea.  
 
‘Increasing age is another risk factor and people can actually have an anatomical risk, which is the cup-to-disc ratio.
 
‘Know that it’s not just GLP-1s that’s the risk, it’s all of those things.’
 
Dr South also points to a low absolute risk, and that while urgent action is required if the condition is suspected,  it is important ‘not to throw the baby out of the bath water’.
 
‘What we’re talking about is between two to 18 additional cases of NAION per 100,000 GLP-1 users per year,’ she said.
 
‘Particularly if someone’s got type 2 diabetes, they should be having once-a-year back-of-the-eye checks and understanding whether they might have additional risk factors, including their cup-to-disc ratio.’
 
According to the Database of Adverse Event Notifications, 36 cases of optic ischaemic neuropathy with GLP-1s have been identified, including 23 for semaglutide, 10 for tirzepatide and three for liraglutide.
 
The TGA noted no cases for dulaglutide although said ‘one semaglutide case had a history of prior dulaglutide use’.
 
It said it first identified a potential link between GLP-1 RAs and NAION in July 2024 after the publication of a JAMA Ophthalmology study.
 
It said it has closely monitored the association since and conducted an independent assessment, which produced conflicting evidence and prompted an October 2025 meeting with the Advisory Committee on Medicines (ACM).
 
The ACM ‘concluded that the current evidence may support the signal for semaglutide, but not dulaglutide or tirzepatide’.
 
‘After considering all available evidence, including the ACM advice, we made a final decision on regulatory actions including [Consumer Medicine Information] and [Product Information] document updates, and publication of safety communications,’ the TGA update states.
 
The new Product Information (PI) for semaglutide products includes the most additional detail.
 
‘It is known that individuals with an anatomical predisposition (“disc at risk”), whether or not they are taking a GLP-1 agonist, are at highest risk of developing NAION,’ the updated PI now reads.
 
‘This pre-existing risk can be assessed by an optometrist or ophthalmologist.
 
‘Some epidemiological studies indicate an increased risk of NAION during treatment with semaglutide.’
 
It said there is ‘no identified time interval’ for the development of NAION.
 
Both the European Medicines Agency and the World Health Organization last year issued product alerts for semaglutide and a potential increased risk of NAION.
 
Last year, the TGA issued a separate safety warning for rare but serious side effects linked with several GLP-1 RAs, including a correlation with increased risk of suicidal thoughts. Mounjaro was also linked to a potentially reduced effectiveness of oral contraception.
 
‘Updates should not imply a causal association, but reflect a class level awareness,’ the TGA said.
 
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GLP-1s ischaemic optic neuropathy NAION non-arteritic anterior ischaemic optic neuropathy TGA