Health · Pharma & Biotech · 24 mins ago
FDA warns of rare eye condition risk with GLP-1 drugs
The FDA warned that GLP-1 drugs may carry a rare eye risk on Monday.
The condition, called NAION or an “eye stroke,” happens when the optic nerve does not get enough blood.
It can cause sudden vision loss and, in severe cases, blindness.
There are no proven treatments for the condition.
The FDA is requiring drugmakers to tell patients and doctors about the potential risk.
GLP-1 drugs such as Ozempic, Wegovy, Mounjaro and Zepbound are widely used for their weight-loss effects, and side effects can emerge in widespread real-world use even if they were not seen in clinical trials.
The US Food and Drug Administration is requiring labels for four GLP-1 drugs to warn about a potential increased risk of a rare eye condition.
The condition, non-arteritic anterior ischemic optic neuropathy, or NAION, can cause sudden, painless vision loss and may permanently impair sight.
The drugs named are Ozempic and Wegovy, made by Novo Nordisk, and Mounjaro and Zepbound, made by Eli Lilly.
The FDA said it reviewed clinical trial, animal and post-marketing data, including observational studies and case reports.
Regulators and researchers say the risk is rare, and its frequency among people taking the drugs is not clear.
- Who
- The US Food and Drug Administration. The warning concerns patients and health care providers using GLP-1 drugs.
- What
- The FDA is requiring four GLP-1 drugs to add label information about potential NAION risk.
- When
- Monday, November 9, 2026.
- Where
- The United States.
- Why
- The FDA reviewed clinical trial, animal and post-marketing data, including observational studies and case reports, about a potential increased risk of NAION.
This story does not have two clearly opposing sides.
The European Medicines Agency’s safety committee said semaglutide may in very rare cases cause NAION.
Britain’s drug regulator added a NAION warning to weight loss drug labels.
The FDA announced that four GLP-1 drugs must add information about potential NAION risk to their labels.
- Drugs named
- Ozempic, Wegovy, Mounjaro and Zepbound
- Condition
- Non-arteritic anterior ischemic optic neuropathy (NAION)
- EMA estimate
- Up to 1 in 10,000 people taking semaglutide for at least one year
- Denmark
- Four patients who experienced vision loss after using Novo Nordisk GLP-1 drugs were granted compensation
- FDA review
- Clinical trial, animal and post-marketing data, including observational studies and case reports
5 sources
FDA issues new warning for Ozempic saying it can cause blindness with 'eye stroke' side effect
FDA orders new vision loss warning for GLP-1s
US FDA orders new eye risk warnings for Ozempic, Zepbound
FDA Slaps New Safety Warning on GLP-1 Drugs
STAT+: FDA warns GLP-1 drugs carry potential risk of rare eye condition
What people are saying
But the best estimates thus far suggest a twofold increase in risk with these medications, and that typically only occurs in patients at high risk.
theoretically be linked to rapid improvement in glycemia