FDA adds vision loss warning to popular weight loss drugs
Regulators are requiring labels to mention a rare optic nerve condition linked to Ozempic, Wegovy, Zepbound, and Mounjaro.
By Tessa Cooper ·
The Food and Drug Administration issued a safety warning on Monday stating that widely used obesity medications may increase the risk of a rare eye condition that can cause permanent vision loss. The agency identified the condition as non-arteritic anterior ischemic optic neuropathy, or NAION. This disorder results from restricted blood flow to the optic nerve, causing swelling and cell death that damages the nerve abruptly.
The FDA is now requiring manufacturers of GLP-1 receptor agonist drugs to include this warning on their product labels. The affected medications include Ozempic, Wegovy, Zepbound, and Mounjaro. The communication notes a potential increased risk, though it does not specify the exact mechanism by which these drugs might contribute to the condition.
NAION is uncommon in the general population. The American Academy of Ophthalmologists estimates the condition occurs in two to 10 people per 100,000. Determining a direct link to GLP-1 drugs is complicated because the primary risk factors for NAION are common among patients taking these medications. These risk factors include diabetes, cardiovascular disease, high blood pressure, high cholesterol, metabolic syndrome, and obstructive sleep apnea.
The initial evidence suggesting a connection came from a 2024 study by Harvard researchers published in JAMA Ophthalmology. The study examined 710 patients with diabetes and 979 patients with overweight or obesity. Participants were divided into groups taking semaglutide or non-GLP-1 treatments. After 36 months, researchers observed higher rates of NAION in the semaglutide groups.
Among the diabetes patients, 8.9 percent of those on semaglutide developed the eye condition, compared to 1.8 percent in the non-GLP-1 groups. In the overweight and obesity cohort, 6.7 percent of patients on the drug had NAION, while only 0.8 percent in the control group did. The data showed a clear disparity between the two treatment arms in both patient populations.
Researchers noted several limitations in the study design. The participants were all from a single referral center that treated most of the regional NAION cases, which may have introduced selection bias. The incidence rates in the study were much higher than general population averages. The study also did not account for the severity of diabetes, which influences NAION risk, and it did not explain how the drugs might cause the condition.
