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![\"Semaglutide](\"https:\/\/www.newsbeep.com\/ie\/wp-content\/uploads\/2026\/07\/1784863154_382_attachment.aspx.jpeg\")
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\n The TGA has issued a new safety update following reported adverse events.
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\n News<\/p>\n
\n Product warnings have been updated due to the high-profile treatment\u2019s potential to cause a rare, but severe, form of eye disorder.
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\n The TGA has issued a new safety update following reported adverse events.
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newsGP weekly poll
\n 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.
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\nIn a safety update published on Thursday<\/a>, the regulator made a class-wide warning covering all GLP-1 RA medicines currently on sale in Australia.
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\nThese include semaglutide (sold as Ozempic and Wegovy), tirzepatide (Mounjaro), liraglutide (Saxenda) and dulaglutide (Trulicity).
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\nThe TGA described the eye disorder, non-arteritic anterior ischaemic optic neuropathy (NAION), as \u2018a rare but serious condition that may result in permanent visual impairment, including blindness and no treatment has been shown to improve visual acuity outcomes\u2019.
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\nIt 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.
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\nThe update follows previous concerns<\/a> of a possible link between taking the medications and the condition.
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\nDr Terri-Lynne South, Chair of RACGP Specific Interests Obesity, said GPs should expect an increase in inquiries following the update.
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\n\u2018It\u2019s really important for GP\u00a0prescribers to understand that there are a number of risk factors for the NAION, which includes reasons that people might be on the medication,\u2019 she told newsGP.
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\n\u2018For example, type 2 diabetes is a risk factor for this eye condition, so is high blood pressure, so is\u00a0obstructive sleep\u00a0apnoea.\u00a0\u00a0
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\n\u2018Increasing age is another risk\u00a0factor\u00a0and people can actually have an anatomical\u00a0risk, which is the cup-to-disc ratio.
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\n\u2018Know that\u00a0it\u2019s\u00a0not just GLP-1s that\u2019s\u00a0the risk,\u00a0it\u2019s\u00a0all of\u00a0those things.\u2019
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\nDr South also points to a low absolute risk, and that while urgent action is required if the condition is suspected, \u00a0it is important \u2018not to throw the baby out of the bath water\u2019.
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\n\u2018What\u00a0we\u2019re\u00a0talking about is between\u00a0two\u00a0to\u00a018\u00a0additional\u00a0cases of NAION per 100,000 GLP-1 users per year,\u2019 she said.
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\n\u2018Particularly if\u00a0someone\u2019s\u00a0got type 2\u00a0diabetes, they should be having\u00a0once-a-year back-of-the-eye checks and understanding whether they\u00a0might have additional\u00a0risk factors, including their cup-to-disc ratio.\u2019
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\nAccording to the Database of Adverse Event Notifications<\/a>, 36 cases of optic ischaemic neuropathy with GLP-1s have been identified, including 23 for semaglutide, 10 for tirzepatide and three for liraglutide.
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\nThe TGA noted no cases for dulaglutide although said \u2018one semaglutide case had a history of prior dulaglutide use\u2019.
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\nIt said it first identified a potential link between GLP-1 RAs and NAION in July 2024 after the publication of a JAMA Ophthalmology study<\/a>.
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\nIt 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).
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\nThe ACM \u2018concluded that the current evidence may support the signal for semaglutide, but not dulaglutide or tirzepatide\u2019.
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\n\u2018After 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,\u2019 the TGA update states.
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\nThe new Product Information (PI) for semaglutide products includes the most additional detail.
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\n\u2018It is known that individuals with an anatomical predisposition (\u201cdisc at risk\u201d), whether or not\u00a0they are taking a GLP-1 agonist,\u00a0are at highest risk of developing NAION,\u2019 the updated PI now reads.
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\n\u2018This\u00a0pre-existing risk can be assessed by an optometrist or ophthalmologist.
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\n\u2018Some epidemiological studies indicate an increased risk of NAION during treatment with semaglutide.\u2019
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\nIt said there is \u2018no identified time interval\u2019 for the development of NAION.
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\nBoth the European Medicines Agency and the World Health Organization last year issued product alerts for semaglutide and a potential increased risk of NAION.
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\nLast year, the TGA issued a separate safety warning<\/a> 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.
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\n\u2018Updates should not imply a causal association, but reflect a class level awareness,\u2019 the TGA said.
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\n GLP-1s<\/a> ischaemic optic neuropathy<\/a> NAION<\/a> non-arteritic anterior ischaemic optic neuropathy<\/a> TGA<\/a>
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\n As a GP, would you work more hours in the after-hours period if there was more funding for this work, such as higher rebates or other incentives?<\/p>\n","protected":false},"excerpt":{"rendered":"
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