FDA orders NAION warning for Ozempic, Wegovy and Mounjaro over possible eye problems

What the FDA decided

The US Food and Drug Administration (FDA) issued a Drug Safety Communication on 9 November 2026 requiring every maker of a GLP-1 receptor agonist to add information about non-arteritic anterior ischaemic optic neuropathy (NAION) to the Warnings and Precautions section of its product labelling. According to the Financial Times, the FDA described NAION as a rare but serious condition that can cause acute, painless, decreased vision in one eye, including permanent vision loss.

The requirement covers the whole class rather than a single brand. Ophthalmology Times reported that it applies to semaglutide (Ozempic, Rybelsus, Wegovy), liraglutide, dulaglutide, exenatide, tirzepatide (Mounjaro, Zepbound) and the oral medicine orforglipron. The FDA noted that NAION cases have been reported after marketing for every GLP-1 medicine currently sold.

Novo Nordisk told the Financial Times that patient safety was a top priority, that it would keep working with health authorities around the world, and that it remained confident the benefits of these medicines outweigh the risks. Eli Lilly did not immediately respond to the newspaper's request for comment.

How strong is the evidence

The FDA said no single data source settled the question and instead weighed several streams of evidence. The largest was a meta-analysis of 126 randomised trials with 134,253 patients. It found NAION in 6.4 per 100,000 person-years among people on GLP-1 medicines, compared with 3.8 per 100,000 person-years among those on comparison treatments.

In US Sentinel data on adults with type 2 diabetes, starting a GLP-1 medicine was linked to a higher NAION risk than starting a DPP-4 inhibitor (hazard ratio 1.43). The comparison with SGLT-2 inhibitors (hazard ratio 1.19) was not statistically significant. The agency also said animal studies have not identified a mechanism, and it describes a potential increased risk of rare events rather than a proven cause.

The concern gained attention after a July 2024 study in JAMA Ophthalmology linked semaglutide to higher NAION risk in a neuro-ophthalmology clinic group. An editorial in the Annals of Medicine and Surgery pointed out that those figures came from a specialised patient group over three years, that the study showed a link but not causation, and that the absolute risk remains low. The FDA puts background NAION rates at 2.3 to 10.2 cases per 100,000 people a year in adults over 50.

Symptoms linked to Mounjaro eye problems and other GLP-1 medicines

According to Ophthalmology Times, the FDA wants patients told to report straight away any of the following, usually in one eye:

• sudden, painless loss of vision, often noticed on waking
• blurred vision or missing patches in the field of vision
• changes in how colours look
• reduced sharpness of central vision

Prescribers are advised to refer anyone with suspected NAION promptly to an eye specialist. If NAION is confirmed, the FDA recommends that prescribers consider discontinuing the GLP-1 medicine unless the benefits clearly outweigh the risks. The agency also notes that people with a past episode of NAION face a higher risk of recurrence, and that an episode in one eye raises the risk in the other. Anyone with eye symptoms or questions about their treatment should speak to a doctor or pharmacist. See the medical disclaimer.

What it means for South Africa

The FDA ruling applies to US labelling. The reports on the decision do not mention any step by the South African Health Products Regulatory Authority (SAHPRA). Ozempic, Extensior, Wegovy, Semagard and Rybelsus are registered with SAHPRA as semaglutide medicines.

Europe acted earlier on semaglutide alone. In June 2025 the European Medicines Agency's safety committee concluded that NAION is a very rare side effect of semaglutide, affecting up to 1 in 10,000 users, and recommended updates to product information. The FDA action goes further by covering the whole GLP-1 class.

The editorial in the Annals of Medicine and Surgery noted that the FDA advises obtaining semaglutide only through registered pharmacies and licensed healthcare providers, and warned that fake versions of these drugs can be dangerous. Readers comparing options can see the semaglutide pharmacy rating for South Africa, which covers registered pharmacies only.