Jul 24, 8:01 AM

Australia puts a vision warning on popular GLP-1 drugs

Ozempic, Wegovy and Mounjaro remain available, but Australian regulators now want sudden sight loss treated as an emergency, not a nuisance.

Australia puts a vision warning on popular GLP-1 drugs

Australia has added a new warning to one of the most commercially successful drug classes of recent years. The Therapeutic Goods Administration says several GLP-1 receptor agonists used for diabetes and obesity, including Ozempic, Wegovy and Mounjaro, may be linked to a rare eye disorder that can lead to permanent vision loss. The drugs are not being pulled, which will disappoint neither patients nor manufacturers, but the regulator has decided the risk is serious enough to spell out in black and white.

The condition in question is non-arteritic anterior ischaemic optic neuropathy, or NAION for short, a disorder that can leave people with lasting visual impairment. The TGA says no treatment has been shown to improve visual acuity once it develops. That is not the sort of detail anyone wants buried in the small print, so product information for Australian patients has now been updated.

The immediate advice is straightforward. People taking these medicines are being told to seek urgent medical attention if they experience sudden vision loss, including partial loss of sight. The regulator has not told patients to stop treatment on their own, and it has not introduced new prescription restrictions. In the modern pharmaceutical world, that is almost a model of restraint.

The warning did not come out of nowhere. The TGA says it first became aware of a possible link in 2024 after a study in a peer-reviewed medical journal raised concerns, and it has been monitoring the issue since then. It carried out its own assessment of the evidence, but found it conflicting, which is often the polite way of saying that the data are messy and nobody should pretend otherwise. It then asked the national advisory committee on medicines whether more risk-mitigation measures were needed.

The answer was yes. The committee concluded that the current evidence justified further action, including updated consumer and clinical safety warnings. The national database of suspected adverse events has recorded 36 cases linked to these drugs. Ozempic and Wegovy account for 23 of them, Mounjaro for 10 and Saxenda for three. No cases were reported for dulaglutide, which is used in Trulicity, although one semaglutide case involved a patient who had previously used dulaglutide.

Specialists have been keen to keep the warning in proportion. Prof Helen Danesh-Meyer of the Royal Australian and New Zealand College of Ophthalmologists said NAION is very rare and should be viewed against the much more common conditions these medicines are used to treat, including heart attacks, stroke and kidney disease. Her view was that, for many patients, the benefits may still outweigh the risk, and that doctors do not need to withhold the medication unless there are underlying eye conditions.

That is the practical message regulators and doctors now have to manage: a medicine class that has changed treatment for diabetes and obesity, and a safety signal that cannot simply be waved away. Patients should not ignore sudden changes in vision, and they should not make their own decisions about stopping treatment. Regulators, meanwhile, have done what regulators do when the evidence is uneasy but not conclusive: they have added a warning and left the market intact.

Written by Freya Stensrud freya.stensrud@alpineweekly.com