Photo: INDRANIL MUKHERJEE / AFP / Getty Images
The US Food and Drug Administration (FDA) will now require makers of popular diabetes and weight loss drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound to add new warnings about a rare but serious eye condition that may cause sudden and permanent vision loss. The new warnings come after the agency reviewed evidence linking these medications, known as GLP-1 receptor agonists, to non-arteritic anterior ischemic optic neuropathy (NAION), a condition that affects blood flow to the optic nerve and can result in painless, acute vision loss.
According to a statement from the FDA, the agency examined data from clinical trials, animal studies, and post-marketing reports, including observational studies and case reports. The FDA’s review follows earlier findings from the European Medicines Agency, which also suggested a possible link between these drugs and NAION.
A large study cited by CNN found that the risk of developing NAION more than doubled after two years of treatment with a GLP-1 drug compared to other diabetes medications. The FDA noted that risk factors for NAION can overlap with common conditions among GLP-1 users, such as Type 2 diabetes, high blood pressure, and sleep apnea.
The new warning will be added to the “warnings and precautions” section of the drug labels for products including Novo Nordisk’s Ozempic and Wegovy, as well as Eli Lilly’s Mounjaro and Zepbound, and several older GLP-1 medications. The FDA said, "patients and caregivers should be aware of a potential increased risk of NAION, a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss."
The FDA did not identify a clear mechanism for how these drugs might increase the risk of the eye condition but emphasized the importance of monitoring for symptoms such as sudden vision changes. The labels for these drugs already contain other safety warnings, including for pancreatitis, gallbladder issues, kidney injury, and a black box alert for possible thyroid tumors.
The FDA’s new labeling requirement is effective immediately. Patients taking GLP-1 drugs for diabetes or weight loss are advised to contact their healthcare provider right away if they notice any changes in vision.