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GLP-1 RAs and rare vision disorder

Medicine Safety Update

Safety information updated across class

Published

Summary

Product warnings across the glucagon-like-peptide-1 receptor agonist (GLP-1 RA) class of medicines have been updated due to the potential for these products to cause a rare, but severe, form of eye disorder.

The GLP-1 RA class of prescription medicines are used primarily to manage type 2 diabetes mellitus and obesity.

The eye disorder, non-arteritic anterior ischaemic optic neuropathy (NAION), is 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 GLP-1 RA class of medicines currently marketed in Australia are:

* Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA.

Trulicity and Ozempic are available on the PBS for diabetes mellitus type 2 (authority streamlined).

What health professionals should do

Be alert to the new class-wide warnings in the Product Information (PI) documents for GLP-1 RAs (see ‘Updates to the Product Information’ below).

Advise patients to seek urgent medical attention if they experience sudden vision loss, including partial loss of vision.

The Consumer Medicine Information (CMI) leaflets for each product will be aligned with the updated PI documents and these should be provided to patients, if deemed clinically appropriate, as part of the counselling process.

Report any side effects to us via the TGA website.

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:

Semaglutide

4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE:

Non-arteritic anterior ischaemic optic neuropathy (NAION)

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 non-arteritic anterior ischaemic optic neuropathy (NAION). 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. There is no identified time interval for when NAION may develop following treatment start. Patients reporting a sudden loss of vision (including partial loss) should be urgently referred for ophthalmological examination and treatment with semaglutide should be discontinued if NAION is confirmed (see section 4.8 ADVERSE EFFECTS).

4.8 ADVERSE EFFECTS

Post-Market Adverse Effects

  • Eye disorders: Non-arteritic anterior ischaemic optic neuropathy (NAION)

Cases of NAION have been reported with GLP-1 RAs, including semaglutide. A sudden loss of vision should lead to ophthalmological examination.

Dulaglutide and Tirzepatide

4.8 ADVERSE EFFECTS

Postmarketing data

Eye disorders - Events of non-arteritic anterior ischaemic optic neuropathy (NAION), a rare condition associated with the potential for decreased vision including permanent loss of vision, have been reported in patients treated with products with GLP-1 receptor agonist activity. A sudden loss of vision should lead to ophthalmological examination.

Liraglutide

4.8 ADVERSE EFFECTS

Post-marketing adverse effects:

Non-arteritic anterior ischaemic optic neuropathy (NAION): Cases of NAION have been reported with GLP-1 RAs, including liraglutide. A sudden loss of vision should lead to ophthalmological examination.

References

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

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