GLP-1 RAs And Rare Vision Disorder

TGA

What health professionals should do

Background

We first identified the potential association of GLP-1 RAs and NAION in July 2024 following a study published in JAMA Ophthalmology.¹ Since then, the association has been closely monitored including through analysis of Australian cases reported to us, and investigations and regulatory actions by overseas regulators.

We conducted an independent assessment of the potential association between GLP-1 RAs and NAION. As the available evidence was conflicting, we sought expert advice from the Advisory Committee on Medicines (ACM) on whether the evidence supported additional risk mitigation measures.

Following discussion at its October 2025 meeting, the ACM concluded that the current evidence may support the signal for semaglutide, but not dulaglutide or tirzepatide and recommended a range of risk mitigation strategies, including:

updates to the PI and CMI documents
communication to relevant health professionals, including general practitioners, optometrists and ophthalmologists.

After considering all available evidence, including the ACM advice, we made a final decision on regulatory actions including PI and CMI document updates, and publication of safety communications.

Adverse events reported to us

A search of our Database of Adverse Event Notifications (DAEN) found 36 cases of optic ischaemic neuropathy with GLP-1 RAs, 23 for semaglutide and 3 for liraglutide, 10 for tirzepatide. No cases were found for dulaglutide, though one semaglutide case had a history of prior dulaglutide use.

Updates to Product Information

Australian PI documents have been updated with the following wording:

References

Hathaway JT et al.. Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide. JAMA Ophthalmology. 2024. 142(8):732-739.

Background

Adverse events reported to us

Updates to Product Information

References

Further reading

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