FDA Requires New Blindness Risk Warning for Ozempic and Wegovy
WHO:
The Guardian - Sanofi’s Soliqua is among the GLP-1 medications covered by the FDA warning.
The Guardian - Novo Nordisk said it believes the data “do not establish a cause-and-effect relationship” and remains confident in the benefit-risk profile of its GLP-1 medicines.
Fast Company - The U.S. Food and Drug Administration (FDA) requires makers of GLP-1 drugs to add a warning about nonarteritic anterior ischemic optic neuropathy (NAION).
Fast Company - The warning applies to Ozempic, Wegovy, Zepbound, Mounjaro, older GLP-1 agonists, and Foundayo, Eli Lilly’s GLP-1 pill.
BBC News - The FDA says Ozempic, Wegovy, and other weight-loss drugs must carry labels about NAION.
WHAT:
The Guardian - The FDA reviewed 126 clinical trials involving more than 134,200 patients, identifying 15 probable NAION cases: 10 among GLP-1 patients, five among placebo recipients, and none among patients taking non-GLP-1 glucose-lowering medications.
The Guardian - The FDA reported NAION incidence rates of 6.4 cases per 100,000 person-years among GLP-1 patients, versus 3.8 cases among patients taking placebo or alternative glucose-lowering medications.
The Guardian - The FDA said there is no treatment to reverse vision loss from NAION.
Fast Company - Prescription labels will describe a possible increased risk of sudden vision loss from NAION in the “warnings and precautions” section.
Fast Company - NAION can cause sudden decreased vision in one eye and may result in permanent vision loss.
Fast Company - The FDA wrote, “NAION cases have been reported for all currently marketed GLP-1 [receptor agonist] products.”
Fast Company - The FDA assessed the risk as very low but statistically significant enough to report.
Fast Company - The FDA cited a general-population NAION incidence of 2.3 to 10.2 cases per 100,000 people per year among adults older than 50.
Fast Company - The European Medicines Agency reported that several large epidemiological studies associated semaglutide exposure in adults with type 2 diabetes with approximately twice the NAION risk compared with people not taking the medicine; it categorized the side effect as “very rare” and said it could affect 1 in 10,000 users.
WHERE:
Fast Company - The FDA warning is for prescription drug labels in the United States.
WHY:
BBC News - The FDA said it is not known why people taking GLP-1 drugs may be more at risk for NAION.
Fast Company - A 2024 observational study found semaglutide use among people with diabetes was associated with NAION; the study could not establish causation.
Fast Company - The FDA launched a “comprehensive evaluation” of research, including clinical-trial data, animal data, case reports, and other observational studies.
Fast Company - The FDA noted that NAION risk factors may include smoking, diabetes, high blood pressure, sleep apnea, anemia, and kidney disease.
HOW:
The Guardian - Novo Nordisk said it continues to monitor medicine safety, review new research, and work with health authorities around the world.
Fast Company - NAION occurs when blood flow to the front of the optic nerve decreases; its causes are not fully understood.
Fast Company - The FDA advises people with sudden, painless vision changes in one eye to report symptoms immediately to a health provider.
(UPDATED November 11, 2026 10:00 UTC)
The FDA is requiring warning labels on GLP-1 drugs about possible sudden vision loss. The rare eye condition can permanently damage vision, but the risk remains very low. Novo Nordisk disputes a proven cause, while regulators advise reporting sudden vision changes immediately.
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(UPDATED November 10, 2026 22:06 UTC)
The FDA is requiring warning labels on GLP-1 drugs, including Ozempic and Wegovy. They’ll describe a very low risk of sudden, potentially permanent vision loss. People experiencing sudden, painless vision changes in one eye should contact a healthcare provider immediately.