Australia’s medicines regulator has issued warnings for several type ۲ 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-۱ RA medicines marketed in Australia as Ozempic, Wegovy and Mounjaro, among other products, were linked to ۳۶ 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”.
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.
“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 ۲۰۲۴ 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-۱ 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.
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The national database of suspected adverse events involving medicines has recorded ۳۶ cases of the eye disorder linked to the drugs. Ozempic and Wegovy accounted for ۲۳ of the cases, with Mounjaro accounting for ۱۰ and Saxenda for three.
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.”
