Drug regulators on Nov. 9 announced that they’re requiring manufacturers of weight loss and diabetes drugs to warn consumers that the drugs could increase the risk of a serious eye condition.
The popular glucagon-like peptide-1 (GLP-1) receptor agonist drugs, such as Ozempic and Zepbound, have been linked to a potential heightened risk of non-arteritic anterior ischemic optic neuropathy (NAION), the Food and Drug Administration said in a safety communication.
NAION, typically caused by decreased blood flow to the front part of the optic nerve, can lead to sudden, painless vision loss, which can become permanent. Most cases involve one eye at a time.
All manufacturers of GLP-1 receptor agonist medications, which are used to treat diabetes or for weight loss, will be required to place a written warning on labels for their drugs moving forward, the FDA said.
“Patient safety is Lilly’s top priority. The FDA’s drug safety communication applies to all medicines with GLP-1 RA activity and does not reference any findings specific to Lilly medicines,” a spokesperson for Eli Lilly, which makes Zepbound and several other GLP-1 drugs, told The Epoch Times in an email.
“We are carefully evaluating the update and will respond to FDA promptly. As always, we will remain in close contact with the agency and continue to review all available data, including any data regarding ophthalmic events. If anyone is experiencing side effects when taking a Lilly medicine, they should talk to their doctor or other healthcare professional.”
A spokesperson for Novo Nordisk, which makes some of the other GLP-1s, did not return a request for comment by publication time.
The FDA began investigating the issue after the 2024 publication of a study that identified a potential risk of NAION with Ozempic and Wegovy. Researchers found more NAION incidents among the study population prescribed Ozempic or Wegovy than among people who were not.
“As this was an observational study, future study is required to assess causality,” the researchers wrote at the time.
The FDA said on Nov. 9 that there were limitations to the study but regulators determined it needed to assess the potential increased risk, so it started looking at data from clinical trials, animal studies, and safety reports that came in after approval of the drugs.
In animal studies, regulators were unable to identify a mechanism for how GLP-1 medications could lead to NAION. They found 6.4 cases of probable NAION per 100,000 person-years on GLP-1s versus 3.8 cases per 100,000 person-years in the comparison groups that received a placebo or non-GLP-1 medications. They identified a statistically significant jump in the risk of NAION in commercial network data when compared with another drug class called dipeptidyl peptidase-4 inhibitors. And they reviewed observational studies that indicated an increased risk among GLP-1 recipients. However, they found no statistically significant increase compared with SGLT-2 inhibitors, which are used to treat type-2 diabetes.
“Based on these findings, FDA is requiring that application holders add information about the risk for NAION to the Warnings and Precautions section of labeling of all GLP-1 RAs,” the agency stated.
The European Medicines Agency’s safety committee in mid-2025 had said that NAION was a very rare side effect from semaglutide, such as Ozempic, affecting up to one in 10,000 people. Later in the year, The Danish Patient Compensation Association announced that it awarded compensation to four people who developed NAION after taking Wegovy or Ozempic.
Eli Lilly on Nov. 9 pointed to a review published in April that noted some studies have found an increased risk while others did not. The review authors, eye experts in New Zealand and the United States, said that larger pooled analyses of randomized clinical trials should be run “to definitively assess risk.”
