The FDA ordered GLP-1 drugmakers to warn of permanent vision loss risks
The Food and Drug Administration on Monday ordered makers of all approved GLP-1 drugs to add a warning about a potential increased risk of non-arteritic anterior ischemic optic neuropathy, or NAION, a rare eye condition that can cause permanent vision loss. The requirement covers drugs including Ozempic and Wegovy from Novo Nordisk and Mounjaro and Zepbound from Eli Lilly.
Get The Augerton Digest by email.
The FDA said labels must place the warning in the “Warnings and Precautions” section. NAION can cause sudden, painless vision loss in one eye, including permanent loss, the agency said. NBC News reported that the condition has no known treatment.
CNN reported that a 2025 study of nearly 175,000 people with diabetes taking semaglutide and an equal number taking non-GLP-1 medicines found NAION risk more than doubled after two years. BioSpace reported that the FDA’s assessment followed a 2024 study that found an association between semaglutide and higher risk.
Was this story useful?
What was the main problem? (optional)
Reporting behind this story
- NBC News — FDA orders new warning on GLP-1s over rare eye condition linked to sudden blindness
- CNN — US FDA orders new eye risk warnings for Ozempic, Zepbound
- Anadolu Agency — US orders new warnings for GLP-1 drugs over potential rare vision loss risk
- Gizmodo — FDA Demands New Blindness Warning For GLP-1 Drugs
- wwltv.com — GLP-1 drugs to include new warning about rare eye condition causing sudden blindness, FDA says
- goodmorningamerica.com — FDA orders new warning on GLP-1 drugs over rare eye condition
- biospace.com — FDA orders class-wide GLP-1 label update to include potential risk for rare eye disease