The US FDA requires semaglutide, tirzepatide, and other GLP-1 drugs to include new warnings about the risk of eye disease.

The US drug regulatory agency has required that popular GLP-1 drugs such as Ozempic and Zepbound include warnings of potential eye risks in the label warning section. Relevant pharmaceutical companies have stated they will cooperate with the evaluation, and analysts believe the market impact will be limited.

The US Food and Drug Administration (FDA) on Monday required all drugs with GLP-1 receptor agonist activity to add information about the potential risk of non-arteritic anterior ischemic optic neuropathy (NAION) to the "Warnings and Precautions" section of their labels.

The drugs affected include Eli Lilly's Mounjaro and Zepbound, as well as Novo Nordisk's Ozempic and Wegovy. NAION is an eye disease that can cause sudden, painless vision loss, with some patients suffering permanent vision impairment.

Both pharmaceutical companies have stated they will respond actively. An Eli Lilly spokesperson said that the FDA's drug safety notice applies to all GLP-1 drugs and is not specific to Eli Lilly products. The company is carefully evaluating the relevant updates and will respond promptly to regulatory requirements.

A Novo Nordisk spokesperson said the company continues to believe that current data do not establish a causal relationship and remains confident in the benefit-risk profile of its GLP-1 drugs.

On the market front, Citi analyst Geoff Meacham believes the FDA move may cause brief concern among patients and investors, but given the low incidence of NAION and the significant benefits of GLP-1 drugs for weight control, blood sugar management, cardiovascular, kidney, and sleep apnea, the overall favorable benefit-risk profile should be maintained. The actual impact on prescribing behavior is expected to be limited.

On Monday, Eli Lilly rose 4.5%, and Novo Nordisk rose 2.9%, with the news having no significant impact on share prices.

The FDA stated that before making this label change requirement, it had comprehensively evaluated clinical trial data, animal experiment data, as well as post-market data, including observational studies and case reports.

The pathogenic mechanism of NAION involves reduced blood flow to the anterior part of the optic nerve, but its exact causes remain unclear.

This is not the first time that regulatory agencies have issued warnings regarding the NAION risk of GLP-1 drugs.

According to Reuters, the European Medicines Agency (EMA) safety committee pointed out last year that among patients who had taken semaglutide for at least one year, the incidence of NAION could be as high as 1 in 10,000.

Semaglutide is the active ingredient in Wegovy, Ozempic, and another Novo Nordisk diabetes drug Rybelsus. At that time, this was the first formal confirmation of the side effect by a global regulatory agency.

Existing clinical research data suggest that long-term use of GLP-1 drugs may be associated with an increased risk of NAION.

A large study published in 2025 tracked nearly 175,000 diabetes patients treated with semaglutide, as well as a control group of equal size taking non-GLP-1 drugs. Results showed that after two years of GLP-1 drug treatment, the risk of NAION was more than double compared to other classes of diabetes medications.

On the legal front, the Danish Patient Compensation Association compensated four Danish patients last year who lost vision after using Novo Nordisk GLP-1 drugs.

Although the data above indicates rising risk, analysts generally believe that the label change will have a limited impact on total GLP-1 drug prescriptions.

Geoff Meacham pointed out, NAION is a rare disease, and GLP-1 drugs have accumulated a large body of evidence supporting their benefits for weight loss, glycemic control, and management of various metabolic diseases. This multi-dimensional benefit advantage is the core support for maintaining market confidence.

The regulatory agency’s action is intended to ensure that healthcare providers and patients can weigh their medication decisions with adequate information, rather than directly restricting the use of such drugs.