Australia’s medicines regulator warns of rare eye disorder linked to weight-loss and diabetes drugs
Australia’s medicines regulator has issued a formal safety warning linking a class of drugs used to treat type 2 diabetes and obesity to a rare but potentially blinding eye condition.
The Therapeutic Goods Administration (TGA) said it had identified 36 cases of non-arteritic anterior ischaemic optic neuropathy (NAION) in Australia associated with glucagon-like peptide-1 (GLP-1) receptor agonists — the class of medicines marketed under brand names including Ozempic, Wegovy, Mounjaro, Trulicity and Saxenda.
NAION is caused by a reduction in blood flow to the optic nerve and may result in permanent visual impairment. According to the regulator, no treatment has been shown to improve visual outcomes once the condition develops.
The warning follows a study published in a peer-reviewed medical journal in 2024 that raised concerns about a possible link between the drugs and the condition, according to ABC Australia. The regulator said it had conducted its own independent assessment of the evidence since then.
The affected medicines — semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro), dulaglutide (Trulicity) and liraglutide (Saxenda) — are used to treat type 2 diabetes and, in some cases, obesity. The TGA’s warning said the products had the potential to cause NAION, a condition in which reduced blood flow to the optic nerve can lead to sudden vision loss.
According to the regulator, NAION may result in permanent visual impairment, and there is no evidence of any treatment that can restore visual acuity once the condition develops.
Key claims
- The TGA linked 36 cases of NAION to GLP-1 receptor agonists, as reported by ABC Australia and The Guardian.
- The affected medications include semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro), dulaglutide (Trulicity), and liraglutide (Saxenda), according to both outlets.
- Product information documents for Australian patients have been updated to reflect the new warning, and patients are advised to seek urgent medical attention if they experience sudden or partial vision loss.
- The TGA does not recommend stopping treatment without consulting a doctor, and has not introduced new restrictions on prescriptions.
- Prof. Helen Danesh-Meyer of the Royal Australian and New Zealand College of Ophthalmologists cautioned that NAION remains a very rare condition, and that for many patients the benefits of continuing treatment may outweigh the risks.
- The TGA said it first became aware of the potential link in 2024, following a study published in a peer-reviewed medical journal, and said further evidence has since been closely monitored.
- The World Health Organisation has likewise issued a warning about the risk of NAION from semaglutide medicines, and the European Medicines Agency has recommended updating product information, as reported by ABC Australia.
Key claims
- The TGA’s warning covers type 2 diabetes and obesity treatments including Ozempic and Mounjaro, with 36 reported cases of NAION in Australia.
- NAION is a rare condition caused by reduced blood flow to the optic nerve that can lead to permanent vision loss, with no proven treatment to restore sight once it develops.
- The TGA advises patients not to stop their medication without first consulting a doctor.
- The World Health Organisation and the European Medicines Agency have separately signalled concern about the risk of NAION from GLP-1 medicines.