TGA Updates Safety Information on GLP-1 RAs and Rare Eye Condition NAION

Australia's Therapeutic Goods Administration TGA has updated product information for GLP-1 receptor agonists after identifying a potential association with nonarteritic anterior ischemic optic neuropathy NAION . The regulatory action follows a study published in JAMA Ophthalmology in July 2024 and…

The Therapeutic Goods Administration TGA has announced updates to product information and consumer medicine documents for glucagon-like peptide-1 receptor agonists GLP-1 RAs following a review of a potential link between these drugs and a rare vision disorder.

The regulatory body first identified a possible association between GLP-1 RAs and nonarteritic anterior ischemic optic neuropathy NAION in July 2024. That initial signal came from a study published in JAMA Ophthalmology. Since then, the TGA has closely monitored the situation, including through analysis of Australian cases reported to the agency and through investigations and regulatory actions taken by overseas regulators.

Background and Regulatory Review

The TGA conducted an independent assessment of the potential association between GLP-1 RAs and NAION. Because the available evidence was conflicting, the agency sought expert advice from the Advisory Committee on Medicines ACM . The ACM was asked whether the evidence supported additional risk mitigation measures beyond those already in place.

After considering all available evidence, including the advice from the ACM, the TGA made a final decision on regulatory actions. Those actions include updates to the Product Information PI and Consumer Medicines Information CMI documents. The TGA also decided to publish safety communications and to communicate directly with relevant health professionals, including general practitioners, optometrists and ophthalmologists.

Adverse Event Reports in Australia

A search of the TGA's Database of Adverse Event Notifications DAEN found 36 cases of optic ischaemic neuropathy associated with GLP-1 RAs. The breakdown by specific drug shows 23 cases linked to semaglutide, 3 cases linked to liraglutide, and 10 cases linked to tirzepatide. No cases were found for dulaglutide, though one of the semaglutide cases involved a patient with a history of prior dulaglutide use.

These numbers represent reports submitted to the TGA and are consistent with the signal identified in the JAMA Ophthalmology study. The agency has not specified whether any of these cases resulted in permanent vision loss, but the condition NAION can lead to irreversible damage to the optic nerve.

Updates to Product Information

Australian PI documents for the affected GLP-1 RAs have been updated with the following wording: The exact wording added to the PI documents was not fully reproduced in the source, but the TGA indicated that updates have been made. The source then includes references to further reading from international regulators.

References and Further Reading

The TGA cited the original study that first raised the concern: Hathaway JT et al. Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide. JAMA Ophthalmology. 2024. 142 8 :732-739.

The TGA continues to monitor the safety of GLP-1 RAs and encourages health professionals to report any suspected adverse events to the agency through its adverse event reporting system.

Peptides referenced: Semaglutide, Tirzepatide, Liraglutide, Dulaglutide, Glucagon, GLP-1.