FDA warns of rare ‘eye stroke’ risk from GLP-1 drugs
The Food and Drug Administration (FDA) on Monday required pharmaceutical companies to warn patients and healthcare providers of a potential increased risk of a serious eye condition associated with the use of GLP-1 drugs for weight loss and diabetes.
Non-arteritic anterior ischemic optic neuropathy (NAION), often referred to as an “eye stroke,” is a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss.
It’s caused by a sudden reduction or blockage of blood flow to the front part of the optic nerve.
If the condition has occurred in one eye, there is an increased risk that it will occur in the other eye, FDA said.
NAION cases have been reported for all currently marketed GLP-1 products, the FDA said, including Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound. The agency is requiring companies to add information about that risk to the “warnings and precautions” section of the drug label.
The FDA said it began a comprehensive evaluation of drug data after researchers in 2024 published an observational study linking Ozempic and Wegovy to the eye condition.
Even though FDA identified “several limitations” of the study, the agency determined that further assessment of the potential increased risk for NAION was warranted. The agency evaluated clinical trial data, animal data and post-marketing data, including observational studies and case reports.
