Failure to Warn: Why Current Ozempic Labels Don’t Mention NAION—What the Science Says
Ozempic (semaglutide) and other GLP-1 receptor agonists like Wegovy have become widely prescribed for diabetes management and weight loss. While these medications can be effective, growing reports link them to non-arteritic anterior ischemic optic neuropathy (NAION), a rare but serious eye condition that can cause sudden, irreversible vision loss. Despite these reports, the official labels for Ozempic and Wegovy do not currently warn about NAION, raising questions about whether patients and doctors are being adequately informed about this risk. If you became afflicted with this condition while taking Ozempic or after discontinuing use, contact Leandros A. Vrionedes, P.C., to speak with a New York Ozempic injury lawyer who can evaluate your situation and advise you accordingly.
What Is NAION?
NAION occurs when blood flow to the optic nerve is abruptly reduced or blocked, causing damage to the nerve fibers. Unlike other optic neuropathies, NAION is not caused by inflammation and typically develops suddenly and without pain. Common symptoms include:
- Sudden loss of vision in one eye
- Loss of peripheral or central vision
- Blurred or dim vision
- Visual field defects
NAION is most common in individuals over 50 and often occurs in people with underlying vascular risk factors such as diabetes, high blood pressure, or sleep apnea. Because the vision loss can be permanent, early detection and treatment are critical.
Reports Linking Ozempic to NAION
Since the introduction of semaglutide, case reports and observational studies have documented instances of NAION in patients taking the drug. These include analyses published in JAMA Ophthalmology and other ophthalmology journals, as well as adverse event reports submitted to regulatory agencies. While the overall risk appears low, the serious and irreversible nature of NAION makes even rare cases significant.
Notably, the European Medicines Agency (EMA) has acknowledged NAION as a very rare potential side effect in their pharmacovigilance reviews, recommending that healthcare providers monitor patients for visual changes. The U.S. Food and Drug Administration (FDA), however, has not yet updated the Ozempic label to include a warning for NAION.
Why Doesn’t Ozempic’s Label Mention NAION?
Prescription drug labels are primarily based on data from clinical trials submitted during the approval process. Semaglutide trials were generally large and well-designed but may not have captured very rare adverse events such as NAION, for several reasons:
- Sample size limitations – NAION is uncommon, so even trials with thousands of participants may not include enough cases to detect a statistically significant signal.
- Duration of follow-up – Many clinical trials follow patients for only months to a few years. NAION may develop outside this observation window.
- Exclusion criteria – Patients with prior ocular or vascular conditions were often excluded, reducing the likelihood that NAION would appear in the trial cohort.
Because the initial trials did not report NAION events, the risk did not meet the threshold for inclusion in the official label at the time of FDA approval.
Emerging Evidence From Post-Market Surveillance
After FDA approval, post-market pharmacovigilance has become a critical tool for detecting rare drug side effects. Real-world data, including adverse event reporting systems, insurance claims, and case series published in peer-reviewed journals, have suggested an association between semaglutide use and NAION.
While causation has not been definitively established, the scientific community acknowledges the biologically plausible link: semaglutide can cause rapid weight loss and blood sugar changes that may alter vascular dynamics, which could, in theory, increase the risk of optic nerve ischemia.
This emerging evidence is what has prompted the EMA and other regulatory agencies to issue safety communications recommending vigilance, even if the formal label has not yet been revised.
Why Patients Need to Know About NAION Risk
Because NAION can result in permanent vision loss, patients taking Ozempic or Wegovy need to be alert to early symptoms. The lack of a warning on the label does not mean the risk is nonexistent. Patients should:
- Report any sudden visual changes to an ophthalmologist immediately
- Keep thorough medical records documenting symptoms and treatment
- Discuss ongoing risks with their healthcare provider, particularly if they have other vascular risk factors
Early recognition is essential. While there is no guaranteed treatment to reverse NAION, prompt evaluation can help prevent damage to the second eye and guide supportive care.
Legal Implications: Failure to Warn
The absence of NAION warnings on the Ozempic label raises potential product liability issues. In a “failure to warn” case, a plaintiff must show:
- The drug manufacturer knew, or should have known, about a serious risk.
- The manufacturer failed to adequately inform patients or healthcare providers.
- The failure to warn contributed to the plaintiff’s injury.
Even rare adverse events can trigger liability claims if the manufacturer had sufficient post-market evidence suggesting the risk and did not act promptly to update labeling.
Acting on Knowledge of Risk
Patients affected by NAION while taking Ozempic or Wegovy should document their condition carefully, including ophthalmologic evaluations, medical history, and prescription details. Consulting a product liability attorney experienced in pharmaceutical cases can help victims understand their rights and potential claims.
Contact Ozempic Lawyer Leandros A. Vrionedes Today
At Leandros A. Vrionedes, P.C., we represent patients harmed by prescription medications, including those who have suffered vision loss potentially linked to Ozempic or Wegovy. If you or a loved one has been diagnosed with NAION after taking these medications, contact our office for a free consultation. We can guide you through your legal options, help preserve critical evidence, and work to hold the responsible parties accountable.
Don’t wait. The sooner you act, the better your chances of protecting your rights and pursuing the compensation you deserve.
