Australian regulator warns of ‘rare but severe’ eye disorder linked to GLP-1 drugs like Ozempic | Health

Australia’s medicines regulator has issued warnings for several treatments associated with type 2 diabetes and obesity, including Ozempic and Mounjaro, about the potential to cause a “rare but serious” eye disorder that can lead to blindness.

Warning from the Therapeutic Goods Administration (TGA) It comes after several GLP-1 RA drugs and other products marketed in Australia as Ozempic, Wegovy and Mounjaro were linked to 36 cases of the condition.

The TGA says that the eye disorder (non-arteritic anterior ischemic optic neuropathy (NAION)) can lead to permanent visual impairment and that “no treatments have been shown to improve visual acuity outcomes” once the condition develops.

Product information documents for Australians have been updated to reflect the new warning, urging patients prescribed the drugs to “seek urgent medical attention if they experience sudden vision loss, including partial vision loss.”

However, the TGA does not recommend that patients stop treatment without consulting a doctor first and does not impose new restrictions on prescriptions.

Prof Helen Danesh-Meyer, from the Royal Australian and New Zealand College of Ophthalmologists, said NAION was a “very rare condition” that “needs to be put into perspective” to avoid causing alarm.

“Naturally, blindness is something we all fear. It’s one of people’s biggest concerns,” he said.

“But this is still a very rare condition; other conditions these drugs treat, such as heart attack, stroke, and kidney disease, are also quite common. If it helps manage and prevent life-threatening risks, then it is probably better for that patient to continue treatment.”

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 has since been “closely monitored” for further evidence of potential links.

The regulator said it had carried out an independent assessment of the potential association between GLP-1 RAs and NAION but found that “the available evidence is 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 available evidence warrants further action, including updated consumer and clinical safety warnings.

The national database of suspected drug-related adverse events recorded 36 cases of drug-related eye disorders. 23 of the cases were due to Ozempic and Wegovy, 10 to Mounjaro and three to Saxenda.

No cases have been reported regarding dulaglutide used in the Trulicity product. One of the reported semaglutide cases had a history of previous use of dulaglutide.

The benefits of the drugs are still significant, Danesh-Meyer said.

“These types of drugs have actually revolutionized the treatment of diabetes as well as obesity,” he said.

“Therefore, we suggested to doctors that: [do] There is no need to hide this medication from patients unless there is an underlying eye condition.