FDA Issues Vision Safety Warning for GLP-1 Drugs
The US Food and Drug Administration (FDA) has ordered updated safety warnings for GLP-1 medicines used for diabetes and weight loss, including Novo Nordisk's Ozempic (semaglutide) and Wegovy, as well as Eli Lilly's Mounjaro and Zepbound. The warning follows a review of clinical trials and safety data, focusing on non-arteritic anterior ischaemic optic neuropathy (NAION) — a rare eye condition caused by reduced blood flow to the optic nerve that can lead to sudden, painless and sometimes permanent vision loss, usually affecting one eye.
The FDA has not advised patients to stop taking these medicines as a precaution. Its findings point to a rare potential risk without establishing that the treatments directly cause the condition.
How Serious Is the Eye Risk? Data Explained
The FDA reviewed 126 clinical trials involving 134,253 patients and identified 15 probable NAION cases — 10 among GLP-1 users and five in comparison groups. The regulator calculated:
- An incidence rate of 6.4 cases per 100,000 person-years among GLP-1 users
- 3.8 cases per 100,000 person-years in comparison groups
In plain terms, that is roughly six cases for every 100,000 people treated for a year, compared with fewer than four among those receiving placebo or other treatments. The absolute difference is small, although the potential consequences are serious. The FDA also examined real-world medical records, with mixed findings on whether GLP-1 treatment was associated with increased NAION risk.
Abu Dhabi Research: A Local Perspective
Dr Jamal Muhsen of Al Dhafra Hospitals examined eye-health records of 121 patients, including 30 receiving semaglutide or tirzepatide, in research published in the medical journal Cureus in October. The study found diabetic retinal disease developed or progressed in 40% of treated patients, compared with 50.5% of those without documented exposure. The difference was not statistically significant. "No statistically significant association was detected for the combined retinal endpoint, but estimates were imprecise," the study concluded.
A separate review identified seven regional NAION cases recorded between 2022 and 2025. None involved documented exposure to semaglutide or tirzepatide. Researchers cautioned that the findings "could not quantify or exclude an association." Note that diabetic retinal disease differs from NAION — the latter affects the optic nerve rather than the retina — so these findings cannot determine whether the medicines increase the risk identified by the FDA.
UAE Studies Flag Counselling Gaps
A January study from Ajman University published in Pharmacy Practice examined dispensing practices at 153 community pharmacies across Dubai and the Northern Emirates using simulated patient visits. Researchers found:
- Only 26.8% of pharmacies requested a prescription when approached for Ozempic for weight loss
- In 27% of visits, patients received no counselling
- Basic screening questions were asked in only 3% to 30% of cases, depending on the question
"The study revealed significant gaps in prescription compliance and patient counselling among UAE community pharmacists when dispensing Ozempic," the researchers concluded. A separate July study involving 386 UAE pharmacists focused on tirzepatide (the active ingredient in Mounjaro). The average knowledge score was 27.78 out of 54, with gaps identified involving dosage, adverse effects, contraindications and patient counselling.
Who May Face Greater Risk?
The FDA identifies diabetes, high blood pressure, sleep apnoea, kidney disease, anaemia and smoking among potential risk factors for NAION. Some of these conditions are already present in patients receiving GLP-1 treatment, making it difficult to determine whether an eye complication is associated with the medicine or an underlying health condition.
What Symptoms to Look For
The FDA advises patients to seek immediate medical attention if they experience:
- Sudden vision loss
- Blurred vision
- Blind spots
- Tunnel vision
- Changes in colour perception
NAION can develop without pain, and some patients first notice symptoms when waking up. Doctors are advised to arrange a prompt assessment by an ophthalmologist when the condition is suspected. For patients who develop NAION, the FDA advises healthcare professionals to consider discontinuing GLP-1 treatment unless its benefits clearly outweigh the risks.
Company Response and Patient Advice
Novo Nordisk has maintained that available evidence does not establish a causal relationship between semaglutide and NAION. Eli Lilly has said the FDA's communication applies to the wider GLP-1 medicine category and does not identify findings specific to its products. The latest US labelling requirement does not automatically change prescribing rules in the UAE. For residents already taking these medicines, the FDA's advice is to recognise sudden changes in eyesight, seek medical attention promptly and discuss treatment decisions with their doctor.
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