GLP-1 Drug Labels Have Remained Unchanged on Eye Risk
While international regulators have added warnings for a rare eye condition, U.S. labels for these medications continue without them.
Updated on Sept. 29, 2026 in Diabetes
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The FDA has yet to add warnings for non-arteritic anterior ischemic optic neuropathy (NAION) to the labels of popular GLP-1 agonists like Ozempic and Wegovy. While regulators in the UK, Europe, and Australia have implemented safety updates, the U.S. remains focused on clinical proof of causation.
Why it matters
Regulators require robust evidence of a causal link before updating drug labels to account for potential side effects. As 216 lawsuits regarding these medications proceed in federal court, the U.S. continues to monitor patient data for safety signals.
A 2026 study of veterans found 39.07 cases of NAION per 10,000 GLP-1 users over three years compared to a baseline of 29.33 cases per 10,000 for users of SGLT2 inhibitors. This research remains under review to determine if a direct causal relationship exists.
The players
Food and Drug Administration
The U.S. agency responsible for regulating medications and overseeing safety signaling.
European Medicines Agency
The European Union body that evaluates the safety and authorization of medicinal products.
The details
NAION involves a sudden loss of vision resulting from restricted blood flow to the optic nerve. The FDA utilizes its Sentinel system, which aggregates insurance claims and electronic health record data, to evaluate whether GLP-1 drugs contribute to this condition. Regulatory agencies in other regions have concluded it is a very rare side effect, but the FDA continues to prioritize establishing clinical causation before amending product information.
Timeline
March 2025: The FDA added NAION to its potential safety signal list.
June 2025: The EMA concluded NAION is a rare side effect of semaglutide.
February 2026: The UK issued a safety update on semaglutide.
July 2026: Australia added class-wide NAION warnings for GLP-1 drugs.
2027: A federal court briefing on causation is scheduled.
Health Landscape
The investigation into GLP-1 safety signals is part of the long-term work of the FDA Sentinel system to analyze insurance and health record data. This process marks the standard approach to evaluating potential adverse events before updating clinical labels at a population level.
If you are currently taking a GLP-1 agonist, you should monitor your vision for sudden changes or unexplained loss of sight. Any concerns regarding potential side effects or your current treatment plan are worth discussing with your doctor.
The takeaway
While international regulators have issued warnings for NAION, the FDA has not yet formally updated labels for medications including Ozempic and Wegovy. Patients concerned about potential eye health changes should monitor their vision and maintain open communication with their prescribing physician.
Further reading
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Source note: This article includes information reported by Medical Daily.
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