TGA warns of rare eye disorder (NAION) linked to GLP-1 drugs like Ozempic
Consensus Summary
Australia’s Therapeutic Goods Administration (TGA) has issued warnings about a rare but severe eye disorder called non-arteritic anterior ischaemic optic neuropathy (NAION) linked to GLP-1 drugs like Ozempic, Wegovy, Mounjaro, and Saxenda. Both the Guardian and ABC report 36 cases of NAION associated with these drugs, with 23 involving semaglutide, 10 involving tirzepatide, and 3 involving liraglutide. No cases were reported for dulaglutide. The TGA first identified the potential link in 2024 and advises patients to seek urgent medical attention if they experience sudden vision loss. While the risk is rare, the disorder can lead to permanent visual impairment. The Guardian notes semaglutide has been studied extensively with over 49 million patient years of exposure, while ABC cites a US study of almost 17,000 patients and mentions WHO and EMA warnings from Last June, including a risk estimate of up to 1 in 10,000 users. Both sources emphasize that patients should not stop treatment without consulting a doctor, as the benefits for managing diabetes and obesity remain significant.
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Key details reported by multiple sources:
- 36 cases of NAION linked to GLP-1 drugs reported in Australia
- 23 of the 36 cases involved semaglutide (Ozempic/Wegovy)
- 10 cases linked to tirzepatide (Mounjaro) and 3 to liraglutide (Saxenda)
- No cases reported for dulaglutide (Trulicity)
- TGA first identified the potential link in 2024
- NAION may cause permanent visual impairment, with no proven treatment to improve outcomes
- Patients are advised to seek urgent medical attention for sudden vision loss
Points of Difference
Details reported by only one source:
- One semaglutide case had a history of previously using dulaglutide
- Semaglutide studied in over 49 million patient years with low NAION incidence
- Novo Nordisk states semaglutide’s benefit-risk profile remains favorable
- TGA found available evidence conflicting and sought national advisory committee advice
- Study examined almost 17,000 US patients, finding higher NAION risk with semaglutide
- 70% of NAION patients do not recover vision
- WHO issued a warning about semaglutide and NAION risk in Last June
- EMA recommended updating product information, citing NAION risk up to 1 in 10,000 users
- Optometry Australia advises patients not to stop medication unless experiencing vision changes
Contradictions
Conflicting information between sources:
- The Guardian states 10 cases involved tirzepatide (Mounjaro) and 3 involved liraglutide (Saxenda), while ABC says 10 cases involved tirzepatide and 3 involved liraglutide (Saxenda) but does not specify the drug for the 3 cases
- The Guardian mentions Saxenda specifically for the 3 cases, while ABC attributes the 3 cases to liraglutide without naming Saxenda
Source Articles
Australian regulator TGA warns of ‘rare but severe’ eye disorder linked to GLP-1 drugs like Ozempic
TGA says product information for some diabetes and weight loss drugs updated with warning of NAION disorder Follow our Australia news live blog for latest updates Get our breaking news email , free app or daily news podcast Australia’s medicines regulator has issued warnings for several type 2 diabetes and obesity-related treatments – including Ozempic and Mounjaro – over the potential to cause a “rare but severe” eye disorder that could lead to blindness. The Therapeutic Goods Administration’s
TGA issues warning over rare eye disorder linked to Ozempic-like drugs
The Therapeutic Goods Administration has issued a safety warning for a rare, but serious risk of vision impairment from taking GLP-1-based drugs such as Ozempic and Wegovy.