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FDA adds rare vision-loss warning to popular GLP-1 drugs
The agency cited clinical, animal and post-marketing data, including a 2025 study of nearly 175,000 diabetic patients.
On Monday, the FDA required GLP-1 drugs including Novo Nordisk's Ozempic and Wegovy and Eli Lilly's Mounjaro and Zepbound to add warnings about a potential increased risk of NAION to their labeling.
NAION, a rare condition affecting the optic nerve, causes sudden painless vision loss. The FDA began investigating after a 2024 study suggested patients prescribed GLP-1 drugs were four times as likely to develop the condition.
An FDA assessment of 126 clinical trials involving over 134,000 patients identified 15 probable NAION events. FDA scientists could not identify a mechanism for the increased risk, yet concluded the potential risk warranted additional warnings.
Eli Lilly spokesperson Misty Fuller said the FDA update "does not reference any findings specific to Lilly medicines," while Novo Nordisk maintains confidence in its drugs' safety profile. Lilly shares rose 3.2% and Novo gained 1.2%.
Patients noticing sudden vision loss should contact a healthcare professional, the FDA advised. Last year, Danish Patient Compensation granted compensation to four patients who experienced vision loss after using Novo's drugs, following European Medicines Agency warnings.