FDA Requires New Vision Loss Warnings for Ozempic, Wegovy and Other GLP-1s Over NAION Risk

Officials are urging individuals taking GLP-1 medications to contact their doctors at the first sign of vision problems.

Federal regulators are warning doctors and patients that popular diabetes and weight loss drugs like Ozempic, Wegovy and Mounjaro may increase the risk of a rare eye condition that can cause sudden, irreversible vision loss.

The U.S. Food and Drug Administration (FDA) issued a safety communication on November 9, announcing that all glucagon-like peptide-1 (GLP-1) receptor agonists must carry new label warnings about the potential risk of non-arteritic anterior ischemic optic neuropathy (NAION).

The condition occurs when blood flow to the optic nerve is disrupted, depriving it of oxygen and potentially causing sudden, painless and permanent vision loss.

GLP-1 medications, including Ozempic, Mounjaro, Wegovy, Zepbound and Rybelsus, have surged in popularity in recent years due to their effectiveness in promoting weight loss and controlling blood sugar. However, growing concerns about serious side effects, including stomach paralysis and bowel obstruction, have led to thousands of GLP-1 gastrointestinal injury lawsuits against the drug manufacturers.

GLP-1 Vision Loss Lawsuits

Concerns about GLP-1 vision loss intensified in July 2024, when Harvard researchers published findings linking Ozempic and Wegovy side effects to an increased risk of NAION.

The study found that diabetes patients prescribed semaglutide, the active ingredient in both drugs, faced a 4.28-fold higher risk of NAION compared to those taking other types of diabetes medications. Among overweight and obese patients, researchers identified a 7.64-fold higher risk compared to those prescribed non-GLP-1 weight loss medications.

Individuals nationwide who developed NAION and suffered permanent vision loss after using Ozempic, Wegovy, Mounjaro and other medications are now filing GLP-1 NAION lawsuits against the manufacturers, alleging they failed to adequately investigate the risks and warn patients and doctors about the potential for irreversible blindness.

FDA Study Finds Higher NAION Rates Among GLP-1 Users

The FDA’s November 9 safety communication cites the July 2024 Harvard study as a key reason for launching a broader investigation into the potential link between GLP-1 medications and NAION vision loss.

Federal regulators initially reviewed reports of NAION among GLP-1 users submitted through the FDA Adverse Event Monitoring System (AEMS), formerly known as the FDA Adverse Event Reporting System (FAERS).

“Although FDA identified several limitations of this study, the agency determined that further assessment of the potential increased risk for NAION was warranted. Therefore, FDA undertook a comprehensive evaluation of clinical trial data, animal data, and postmarketing data, including observational studies and case reports.”

— FDA Safety Communication

The agency subsequently conducted a meta-analysis of 126 clinical trials involving 134,253 patients, including 78,217 GLP-1 users and 56,036 individuals receiving a placebo or another diabetes medication.

The review identified 15 probable NAION cases, including 10 among GLP-1 users and five in the comparison groups. Overall, researchers found an incidence rate of 6.4 NAION events per 100,000 person-years among GLP-1 patients, compared with 3.8 events per 100,000 person-years among those receiving other treatments or a placebo.

The FDA also reviewed additional observational studies and real-world patient data, finding further evidence of a potential increased risk of NAION. Importantly, regulators identified reports of NAION involving every currently marketed GLP-1 medication, prompting the agency to require updated warnings across the entire drug class.

FDA GLP-1 Vision Loss Recommendations

In addition to requiring new NAION warnings on GLP-1 drug labels, the FDA is urging patients to immediately contact their health care providers if they experience sudden vision changes while taking medications like Ozempic, Wegovy or Mounjaro.

Potential signs of NAION include sudden, painless vision loss in one eye, blurred vision, blind spots, tunnel vision, distorted colors and reduced sharpness of vision. Symptoms may first appear upon waking, and the resulting vision loss can be permanent.

Federal regulators are also directing doctors to promptly refer patients with suspected NAION to an ophthalmologist for evaluation and consider discontinuing GLP-1 treatment unless the benefits clearly outweigh the risks.

Individuals who have already experienced NAION are advised to discuss with their doctors whether they should continue taking their GLP-1 medications.

GLP-1 NAION Lawsuits

Federal GLP-1 vision loss lawsuits are now being coordinated before U.S. District Judge Karen Spencer Marston in the Eastern District of Pennsylvania, as part of a multidistrict litigation (MDL No. 3163) involving allegations that Ozempic, Wegovy, Mounjaro and other medications caused NAION and permanent vision damage.

Judge Marston is also overseeing a separate MDL No. 3094 involving GLP-1 gastrointestinal injury lawsuits, which allege the medications caused stomach paralysis, bowel obstruction and other serious digestive complications.

As both groups of lawsuits move through coordinated pretrial proceedings, the court is expected to address common evidence and legal challenges before any representative cases are selected for bellwether trials. The outcomes of those early trials could influence potential GLP-1 NAION lawsuit settlement negotiations.

The FDA’s decision to require new NAION warnings is expected to become an important development in the ongoing litigation, as plaintiffs continue to pursue claims alleging the manufacturers failed to adequately investigate and disclose the potential risk of permanent vision loss.

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