Australian regulator 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
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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) warning came after several GLP-1 RA medicines marketed in Australia as Ozempic, Wegovy and Mounjaro, among other products, were linked to 36 cases of the condition
The TGA says the eye disorder – non-arteritic anterior ischaemic optic neuropathy (NAION) – may result in permanent visual impairment and “no treatment has been shown to improve visual acuity outcomes” after the condition develops
Product information documents for Australians have been updated to reflect the new warning, and patients prescribed the drugs are urged to “seek urgent medical attention if they experience sudden vision loss, including partial loss of vision”
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But the TGA does not recommend patients stop treatment without first consulting a doctor, nor has it placed new restrictions on prescriptions
Prof Helen Danesh-Meyer, from the Royal Australian and New Zealand College of Ophthalmologists, said that NAION is “a very rare condition” that “needs to be put in perspective” to avoid causing alarm
“Naturally, blindness is something we all fear. It’s one of the greatest concerns that people have,” she said
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“But it’s still a very rare condition, while the other conditions these medications treat are very common, like heart attacks, stroke and kidney disease. If it helps manage and prevent those life-threatening risks, then for that patient it is probably better to continue it.”
The TGA said it first became aware of the link to NAION in 2024 after a study published in a peer-reviewed medical journal raised concerns, and further evidence of the potential links has since “been closely monitored”
The regulator said it conducted an independent assessment of the potential association between GLP-1 RAs and NAION, but found “available evidence was conflicting” and sought advice from the national advisory committee on medicines on whether the evidence required “additional risk-mitigation measures”
The committee concluded that the current evidence called for further action, including updated consumer and clinical safety warnings
The national database of suspected adverse events involving medicines has recorded 36 cases of the eye disorder linked to the drugs. Ozempic and Wegovy accounted for 23 of the cases, with Mounjaro accounting for 10 and Saxenda for three
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No cases were reported in relation to dulaglutide, which is used in the product Trulicity. One of the reported semaglutide cases had a history of previously using dulaglutide
Danesh-Meyer said the benefits of the medications remain significant
“This kind of medication has actually revolutionised the management of diabetes as well as obesity,” she said
“Therefore, we have suggested that doctors [do] not need to hold this medication … from patients unless they have underlying eye conditions.”
Novo Nordisk, the maker of Ozempic, Wegovy and Saxenda, said “patient safety is a top priority” and that it “continuously monitor[s] the safety profile of our medicines” in collaboration with the TGA and other regulators worldwide
A spokesperson said semaglutide has been studied in “multiple robust clinical development programs with a total exposure from post-marketing use of over 49 million patient years”
“Considering the totality of evidence from clinical trials, post-marketing reports and observational studies, alongside the generally low incidence rate of NAION, Novo Nordisk believes that the benefit-risk profile of semaglutide remains favorable,” the spokesperson said
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