The US Food and Drug Administration (FDA) has issued a new warning for GLP-1 drugs – which may aid weight loss – regarding a rare eye disease that can cause sudden and permanent blindness.
On Monday, the FDA announced that it is requiring all GLP-1 drugs — including Novo Nordisk’s Ozempic and Wegovy, Eli Lilly’s Mounjaro and Zepbound, as well as Sanofi’s Soliqua — to include information about the potential risk of nonarteritic anterior ischemic optic neuropathy, also known as NAION, on warning labels.
NAION is a rare disease involving a sudden reduction in blood flow to the optic nerve, in turn leading to an acute, painless decrease in vision in one eye, including permanent vision loss, the FDA warned.
Common risk factors for NAION include diabetes, smoking, hypertension as well as high cholesterol. It is the most common cause of acute optic nerve injury in people over the age of 50, with an annual average of 2.3 to 10.2 cases per 100,000 people over this age. There is currently no treatment to reverse vision loss due to NAION.
According to the FDA, the agency began examining potential links between GLP-1 and NAION after a 2024 study published in the journal JAMA Ophthalmology. The study found an increased risk of NAION in patients using GLP-1 medications.
Despite identifying several limitations of the study, the FDA said it “determined that further evaluation of the potential increased risk of NAION is warranted.”
The agency conducted a review of 126 clinical trials involving more than 134,200 patients and identified 15 probable cases of NAION, including 10 among GLP-1 patients; five in patients receiving a placebo; and none in patients taking glucose-lowering medications other than GLP-1.
The FDA found an incidence rate of NAION of 6.4 cases per 100,000 person-years in GLP-1 patients, compared to 3.8 cases in patients taking placebo or other hypoglycemic medications.
“NAION cases have been reported for all currently marketed GLP-1 RA products,” the FDA said. “The FDA has concluded that there is a potential increased risk of rare NAION events in patients taking GLP-1 RAs.
“Based on these findings, FDA is requiring applicants to add information about the risk of NAION to the Warnings and Precautions section of the labeling of all GLP-1 RAs.”
In response to the FDA’s announcement, a Novo Nordisk spokesperson told the Guardian that the pharmaceutical company “continues to believe that the data does not establish a cause-and-effect relationship and we remain confident in the benefit-risk profile of our GLP-1 medicines.”
The statement also said: “Patient safety is a top priority for Novo, and we continue to monitor the safety of our medicines, review new research, and work with health authorities around the world. »
The Guardian has contacted Eli Lilly and Sanofi for additional comment. Eli Lilly previously said it was aware of publications regarding the risk of NAION in GLP-1 patients.
GLP-1 medications are primarily used by people with type 2 diabetes to manage their blood sugar levels – or blood sugar levels. Some medications are also used to treat obesity. And some seek access to these medications for cosmetic reasons rather than legitimate medical ones.
The FDA’s announcement comes amid warnings from the Access to Medicine Foundation, a Netherlands-based nonprofit, that the pharmaceutical focus on GLP-1 weight-loss drugs risks endangering the global insulin supply.
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