Safety

Ozempic gets an eye warning in the US. What SA users should know

The US FDA has ordered a warning about a rare eye condition that can cause sudden vision loss on all GLP-1 medicines, including Ozempic and Mounjaro. Here's how big the risk is, the symptoms, and what SAHPRA says.

By Reported Team

An Ozempic semaglutide injection pen lying on a grey surface
Photo: HualinXMN, Wikimedia Commons, CC BY-SA 4.0

The US Food and Drug Administration (FDA) has ordered the makers of every GLP-1 medicine, including Ozempic, Wegovy and Mounjaro, to add a warning about a rare eye condition that can cause sudden vision loss. The agency announced the change in a drug safety communication on 9 November 2026 (FDA).

The condition is called non-arteritic anterior ischemic optic neuropathy, or NAION. The FDA says it can cause "acute, painless, decreased vision in one eye, including permanent vision loss" (FDA).

How big is the risk?

Small, but higher than in people not taking these medicines. The FDA analysed 126 clinical trials and found these rates (FDA):

GroupNAION cases per 100,000 person-years
People taking a GLP-1 medicine6.4
People on a placebo or another glucose-lowering medicine3.8

A person-year is one person taking the medicine for one year. The FDA also said a causal link has not been established, and its scientists could not identify how the drugs might raise the risk (CNBC; NBC News).

Europe reached a similar view earlier. In June 2025, the European Medicines Agency's safety committee concluded that NAION is a very rare side effect of semaglutide, the active ingredient in Ozempic, Rybelsus and Wegovy, affecting up to 1 in 10,000 people who take it (EMA). The World Health Organization flagged the same finding to health workers and regulators (WHO).

Which medicines are affected?

The FDA's order covers all GLP-1 medicines sold in the US (FDA):

BrandActive ingredient
Ozempic, Rybelsus, Wegovysemaglutide
Mounjaro, Zepboundtirzepatide
Victoza, Saxendaliraglutide
Trulicitydulaglutide
Foundayoorforglipron

Does this apply in South Africa?

The FDA's order applies to labels in the US. South Africa's medicines regulator, SAHPRA, had not published its own NAION notice on its semaglutide page when we checked.

SAHPRA's semaglutide FAQ says Ozempic is registered in South Africa for adults with type 2 diabetes, is not registered for weight loss here, and is available only on prescription (SAHPRA). It also warns that products bought outside licensed pharmacies, including compounded versions, have not been checked by SAHPRA for safety (SAHPRA).

What symptoms should I watch for?

The FDA lists these signs of NAION (FDA):

SymptomWhat it can look like
Sudden vision loss in one eyeOften noticed on waking, and painless
Missing parts of visionBlind spots or tunnel vision
Colour changesColours look faded or distorted
Blurry central visionHazy or blurred spots

The FDA says patients should contact their health care professional right away if they have any of these symptoms (FDA).

Should I stop taking my medicine?

Don't stop on your own. The FDA says people who have had NAION should talk to their health care professional about whether to continue or stop the medicine (FDA). The EMA's advice is that semaglutide should be stopped if NAION is confirmed (EMA).

The FDA lists smoking, diabetes, high blood pressure, sleep apnoea, anaemia and kidney disease as possible risk factors for NAION. Someone who has had it in one eye has a higher chance of it happening in the other (FDA).

FAQ

What did the FDA announce about Ozempic and eyesight?

On 9 November 2026 the FDA ordered all GLP-1 medicines, including Ozempic, Wegovy and Mounjaro, to carry a warning about a possible higher risk of NAION, a rare eye condition that can cause sudden vision loss in one eye.

How rare is NAION on GLP-1 medicines?

In the FDA's analysis of 126 trials, there were 6.4 cases per 100,000 person-years on GLP-1 medicines compared with 3.8 on other treatments or placebo. The EMA puts it at up to 1 in 10,000 people on semaglutide.

Is Ozempic registered for weight loss in South Africa?

No. SAHPRA says Ozempic is registered in South Africa for adults with type 2 diabetes and is not registered for weight loss. It is available only on prescription.

What should I do if my vision changes on Ozempic?

Contact your doctor straight away. The FDA says people who have had NAION should discuss with their health care professional whether to continue the medicine.

Sources