US FDA orders new eye risk warnings for Ozempic and Zepbound
NVO•The FDA is requiring GLP-1 drugs including Ozempic and Zepbound to add warnings about a potential increased risk of NAION, a condition that can cause sudden, painless vision loss and may permanently impair sight.
1. FDA requires label changes
The FDA said it is requiring GLP-1 drugs including Eli Lilly's Mounjaro and Zepbound, and Novo Nordisk's Ozempic and Wegovy, to add information about the potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) to the “warnings and precautions” section of their labels. The agency said it reviewed clinical trial, animal and post-marketing data, including observational studies and case reports.
2. Companies respond
A Lilly spokesperson said the communication applies to all medicines with GLP-1 receptor agonist activity and does not reference findings specific to Lilly medicines. A Novo spokesperson said the company believes the data do not establish a cause-and-effect relationship and remains confident in the benefit-risk profile of its GLP-1 medicines.
3. Evidence on NAION
NAION is a common cause of sudden, painless vision loss and may permanently impair sight in some cases. A study published in 2025 that tracked nearly 175,000 diabetic patients treated with semaglutide and an equal number taking non-GLP-1 medicines found the risk of NAION more than doubled after two years of GLP-1 treatment compared with other diabetes medicines.
