FDA orders new warning on GLP-1 drugs over potential risk of blindness

Show caption: Wegovy is among the GLP-1 drugs required to carry a new warn…

Regulator says research linked rare eye condition to medication

The makers of GLP-1 weight loss drugs such as Ozempic, Wegovy and Mounjaro must add a warning label about a possible link to permanent vision loss, the US Food and Drug Administration has said.

The regulator said that it based the decision on research that linked a rare eye condition, called non-arteritic anterior ischemic optic neuropathy (NAION), which can cause blindness, and Glucagon-like peptide-1 medication, which is used to treat obesity and diabetes and has become popular for weight loss.

In a bulletin issued late on Monday, the FDA said it based its decision on clinical trial data, observational studies and a 2024 article that looked at possible connections between NAION and GLP-1 drugs. That article prompted the FDA to look into the matter further.

“The FDA is informing patients and health care providers of a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with use of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications,” the US regulator's bulletin said.

“NAION is a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss.”

Show caption: The Food and Drug Administration said it based its decision …

Patients with a history of NAION, according to the FDA, are at increased risk.

The health regulator indicated that health care providers should consider telling patients to discontinue using GLP-1 medications if signs of NAION arise “unless the benefits of treatment clearly outweigh the risk”.

The medications, which also include Zepbound and Soliqua, must now carry a warning label about the link.

“Data from an analysis of 126 randomised, controlled clinical trials across multiple GLP-1 RAs showed an occurrence of 6.4 NAION cases per 100,000 person-years (PY) in patients treated with GLP-1 RAs compared to 3.8 NAION cases per 100,000 PY for patients treated with a placebo or a non-GLP-1 RA glucose-lowering medication,” the FDA explained.

According to ABC News, Novo Nordisk, the maker of Ozempic and Wegovy, said that “available research does not establish that GLP-1 medications cause NAION”.

Regardless, the FDA is insisting that the drug manufacturers “add information to the warnings and precautions section of labelling about the potential increased risk of NAION associated with use of these medications”.

Updated:

November 10, 2026, 4:59 PM