The US Food and Drug Administration (FDA) has required manufacturers of GLP-1 medications used for weight loss and diabetes management (Ozempic, Wegovy, Mounjaro and Zepbound) to add information about the risk of serious eye damage to the “Warnings and Precautions” section of their drug labels.
The warning concerns a rare condition known as non-arteritic anterior ischemic optic neuropathy (NAION). The condition occurs when blood flow to the front part of the optic nerve is reduced, causing sudden, painless vision loss. In some cases, it can lead to irreversible damage to vision.
The FDA made its decision following a comprehensive analysis of clinical, post-marketing and observational data. This included a large-scale study published in 2025 that examined the medical records of nearly 175,000 patients. The analysis found that after two years of GLP-1 medication use, the risk of developing NAION doubled compared with patients taking other classes of diabetes medications. Notably, the European Medicines Agency (EMA) issued a similar warning last year, explaining that the risk is estimated to affect approximately one in every 10,000 patients.
Pharmaceutical companies Novo Nordisk and Eli Lilly say they are reviewing the regulator’s decision. However, Novo Nordisk maintains that the available evidence does not conclusively establish a direct causal relationship between the medications and eye damage.
According to independent medical and financial analysts, the FDA’s move may cause temporary concern among patients, but it is unlikely to substantially change global prescribing practices. NAION remains an extremely rare complication, while the clinical benefits of GLP-1 medications — including weight loss, improved glycemic control, and the prevention of cardiovascular and kidney diseases — significantly outweigh these risks.
