Lawyers representing complainants in personal injury lawsuits alleging vision loss associated with GLP-1 medications have welcomed the Food and Drug Administration’s (FDA) directive that the popular weight loss drugs must now carry warnings that they can increase the risk of vision loss, reports MedicalBrief.
In a statement released yesterday, Jonathan Orent from US-based Motley Rice Attorneys, and co-lead counsel in non-arteritic anterior ischaemic optic neuropathy (NAION)-related litigation, said doctors have, for too long, lacked a warning about the potentially blinding risk association with GLP-1 medications.
“The FDA’s action reinforces the concerns we’ve raised in court and represents an important step forward for patient safety. Physicians need this information to identify those most at risk and make informed decisions about the benefits and risks of these medications that are prescribed to roughly one in eight American adults,” Orent said.
The FDA announced on Monday that it is requiring manufacturers of GLP-1 medications to warn that they can increase the risk of vision loss. The warning applies to all GLP-1 medications, including popular weight loss drugs like Ozempic and Wegovy, The Washington Post reports.
There is no known treatment for NAION, which is also associated with diabetes, smoking and high blood pressure.
Manjot Gill, a professor of ophthalmology at Northwestern University Feinberg School of Medicine, said that while some data shows an association between GLP-1 use and NAION cases, studies are inconclusive and the absolute risk of a patient developing the condition is still very low.
“This is still a very exceedingly rare condition affecting maybe six in 100 000 patients,” Gill said.
“The caveat, then, that I would make is that if we look at the overall health benefits of these medications … those far outweigh the exceedingly low rate of this complication developing,” she added.
Studies have reached conflicting conclusions about whether GLP-1 drugs raise the risk of NAION, often referred to as “eye stroke”, but lawsuits and some findings have raised concerns about side effects the drugs may carry.
NAION cases have been reported for all currently marketed GLP-1 products, the FDA said.
Eli Lilly, which manufactures weight loss drugs, said in a statement that it is evaluating the update and will respond to the FDA promptly.
“Patient safety is Lilly’s top priority,” the company said. “FDA’s drug safety communication applies to all medicines with GLP-1 RA activity and does not reference any findings specific to Lilly medicines.”
Novo said in a statement to The Washington Post before Monday’s announcement that personal injury lawsuits against the company are “without merit” and that a 2026 study of more than 90 000 participants in clinical trials for the company’s GLP-1 products found no association between the drugs and NAION.
“Considering the totality of evidence from clinical trials, post-marketing reports and observational studies, alongside the generally low incidence rate of NAION, Novo believes that the benefit-risk profile of semaglutide remains favourable,” spokesperson Liz Skrbkova said.
Patients should contact their doctors immediately if they experience symptoms of NAION and discuss whether to continue taking GLP-1s or stop, the FDA said.
Gill said more research is needed to determine if and how GLP-1s cause vision issues. Patients shouldn’t be discouraged from taking GLP-1s due to the FDA’s announcement because of how rare NAION is, but they should immediately report any vision-related symptoms to their doctor, she said.
“Healthcare providers should instruct patients to immediately report sudden onset of acute, painless, decreased vision; visual field deficits; or other visual disturbances in one eye,” the FDA said.
“If NAION is suspected, promptly refer the patient to an ophthalmologist for evaluation. Consider discontinuing the GLP-1 (receptor agonist) … unless the benefits of treatment clearly outweigh the risk.”
NAION occurs when blood flow to the optic disc is reduced. Beyond the painless vision loss, often noticed upon waking, symptoms can include blurred or missing visual fields, colour distortion, and reduced central visual acuity. Its exact triggering mechanism remains poorly understood and animal data on GLP-1 drugs did not further elucidate a potential mechanism for the higher risk observed with the drugs, the FDA said.
The agency’s action follows a wave of studies suggesting a potential link between GLP-1 drugs and NAION, including a 2024 study in JAMA Ophthalmology involving semaglutide (Ozempic, Wegovy) that FDA said prompted its review, according to MedPage Today.
Europe’s drug regulator warned about the risk 17 months ago.
In a meta-analysis of randomised trials performed by the FDA, the agency identified 15 probable NAION events among more than 134 000 patients. Of those, 10 cases occurred among the roughly 78 000 treated with GLP-1 drugs, none was in those randomised to other glucose-lowering medications, and five occurred in placebo recipients.
Incidence was 6.4 cases per 100 000 person-years among the GLP-1 drug recipients compared with 3.8 cases per 100 000 person-years among patients receiving a non-GLP-1 medication or placebo.
A retrospective cohort study performed by the FDA involving type 2 diabetes patients showed no significantly increased risk for NAION with GLP-1 agonists versus SGLT2 inhibitors (HR 1.19, 95% CI 0.91-1.54) but an increased risk was seen compared with DPP-4 inhibitors (HR 1.43, 95% CI 1.02-2.01).
Common risk factors for NAION include smoking, diabetes, hypertension, obstructive sleep apnoea, anaemia, and chronic kidney disease. Patients with a history of NAION carry an increased risk for recurrence.
Patients and clinicians can report suspected adverse reactions associated with GLP-1 medications to the FDA’s MedWatch reporting programme.
MedPage Today article – FDA Slaps New Safety Warning on GLP-1 Drugs (Open access)
The Washington Post – FDA tells GLP-1 makers to warn of potential vision loss side effect (Restricted access)
See more from MedicalBrief archives:
Low overall risk of vision loss with GLP-1 RA use – large Swedish cohort study
Vision problems flagged after GLP-1 agonists – Utah survey
Nordisk slams study linking rare blindness to semaglutide