TGA Issues Class-Wide GLP-1 Warning Over Rare Eye Disorder Linked to Semaglutide and Tirzepatide

Australia's Therapeutic Goods Administration (TGA) published a class-wide safety update on July 23, 2026, revising product warnings for every GLP-1 receptor agonist sold in the country over their potential to cause a rare but severe eye disorder, according to reporting by RACGP's newsGP, Diabetes Australia and Pharmacy Daily. The update covers semaglutide (sold as Ozempic and Wegovy), tirzepatide (Mounjaro, a dual GIP/GLP-1 agonist), liraglutide (Saxenda) and dulaglutide (Trulicity), all of which remain approved medicines on the Australian market.

The condition at issue is non-arteritic anterior ischaemic optic neuropathy (NAION), which the TGA described, as quoted by newsGP, 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.' The agency said there is 'no identified time interval' between starting a GLP-1 drug and the onset of NAION.

The update draws on the TGA's Database of Adverse Event Notifications (DAEN), which has recorded 36 cases of optic ischaemic neuropathy associated with GLP-1 medicines: 23 involving semaglutide, 10 tirzepatide and three liraglutide. No cases were recorded for dulaglutide, though one semaglutide case had a prior history of dulaglutide use, per the TGA figures reported by newsGP and Pharmacy Daily.

The TGA said it first identified a potential link between GLP-1 receptor agonists and NAION in July 2024, after publication of a JAMA Ophthalmology study, and has monitored the association since. An independent assessment produced conflicting evidence, prompting an October 2025 meeting of the Advisory Committee on Medicines (ACM), which newsGP reported 'concluded that the current evidence may support the signal for semaglutide, but not dulaglutide or tirzepatide.' Following that advice, the TGA said it made 'a final decision on regulatory actions including [Consumer Medicine Information] and [Product Information] document updates, and publication of safety communications.' The revised Product Information for semaglutide products now states that people with an anatomical predisposition, described as a 'disc at risk,' 'whether or not they are taking a GLP-1 agonist, are at highest risk of developing NAION,' and that this can be assessed by an optometrist or ophthalmologist.

The Australian update follows earlier action by other regulators: the European Medicines Agency and the World Health Organization each issued product alerts last year flagging a potential increased NAION risk associated with semaglutide, according to newsGP. It is also not the TGA's first GLP-1 safety communication; the agency separately warned last year of rare but serious side effects across several GLP-1 medicines, including a possible link to suicidal thoughts, and flagged that Mounjaro may reduce the effectiveness of oral contraception.

Dr. Terri-Lynne South, chair of the Royal Australian College of General Practitioners' Specific Interests Obesity group, told newsGP that GPs should expect more patient inquiries following the update and pointed to several risk factors independent of GLP-1 use, including type 2 diabetes, high blood pressure, obstructive sleep apnoea, increasing age and an anatomical cup-to-disc ratio. 'What we're talking about is between two to 18 additional cases of NAION per 100,000 GLP-1 users per year,' she said, adding that patients with type 2 diabetes should have annual back-of-the-eye checks and be assessed for additional risk factors.

The TGA advised health professionals to make patients aware of the warning and to recommend urgent ophthalmological examination for anyone who experiences sudden vision loss, including partial loss of vision, while emphasizing that 'updates should not imply a causal association, but reflect a class level awareness,' as quoted by newsGP. The agency has not withdrawn or restricted any of the four medicines, and this report does not constitute medical or dosing guidance; patients with concerns should consult a health professional.