The European Medicines Agency (EMA) has officially confirmed that semaglutide medications—including Ozempic, Wegovy, and Rybelsus—carry a "very rare" but serious risk of causing nonarteritic anterior ischemic optic neuropathy (NAION), a serious eye condition that can cause vision loss. The EU regulatory acknowledgment represents the first time a major health authority has formally recognized this Ozempic side effect, which has impacted thousands of patients worldwide and led to lawsuits in the U.S.
Breaking News: EMA Issues First Official Semaglutide Warning
Following an extensive review of available data, the EMA's safety committee determined that NAION may affect up to 1 in 10,000 people taking semaglutide for at least one year. The agency has mandated that Novo Nordisk update product labeling to include this "very rare" side effect warning—a significant development for patients and healthcare providers who have been largely unaware of this serious risk.
"If patients experience a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, they should contact their doctor without delay," the EMA urgently advised. "If NAION is confirmed, treatment with semaglutide should be stopped."
EMA’s regulatory action stems from mounting scientific evidence, including groundbreaking research published in JAMA, along with multiple large-scale epidemiological studies showing a higher risk of NAION in patients prescribed semaglutide compared with patients prescribed other medications for diabetes or obesity.
What is NAION?
Nonarteritic anterior ischemic optic neuropathy (NAION) is a devastating condition caused by insufficient blood flow to the optic nerve, resulting in sudden, painless vision loss that typically occurs in one eye. According to medical experts, NAION is the second-leading cause of optic nerve blindness after glaucoma, and there is no effective treatment once vision loss occurs.
The condition often strikes without warning, with many patients discovering their vision loss upon waking in the morning. Unlike other forms of vision impairment, NAION typically causes permanent, irreversible damage to the optic nerve, fundamentally altering patients' quality of life and ability to perform daily activities.
Landmark Medical Studies Reveal Alarming Risks
The Mass Eye and Ear Study: A Four to Seven-Fold Increase
The most significant research to date comes from a July 2024 study published in JAMA Ophthalmology, conducted by researchers at Mass Eye and Ear, a Harvard Medical School affiliate. This groundbreaking study analyzed 16,827 patients and revealed shocking results:
- Diabetes patients prescribed semaglutide had a 4.28-fold increased risk of developing NAION.
- Overweight/obese patients showed an even more alarming 7.64-fold increased risk.
- These elevated risks persisted even after accounting for other risk factors.
Dr. Joseph Rizzo, the study's lead author and director of the Neuro-Ophthalmology Service at Mass Eye and Ear, emphasized the significance:
"The use of these drugs has exploded throughout industrialized countries and they have provided very significant benefits in many ways, but future discussions between a patient and their physician should include NAION as a potential risk."
Additional Supporting Research
Research linking Ozempic to vision loss is not limited to the 2024 JAMA study; multiple independent studies over the last few years have corroborated these concerning findings:
- A February 2025 study in JAMA Ophthalmology tracking data from multiple databases found a statistically significant increase in NAION risk among semaglutide users.
- Recent analysis of FDA adverse event data showed a disproportionately higher rate of NAION among semaglutide users compared to other GLP-1 medications.
- Large epidemiological studies consistently demonstrate approximately a two-fold increase in NAION risk for type 2 diabetes patients using semaglutide.
The Human Cost: Real Stories of Ozempic Vision Loss
The statistics represent real people whose lives have been forever changed. Todd Engel, a Maryland resident, describes the devastating impact: "This isn't just about me not being able to see or go to work anymore. This is also about being unable to see my loved ones, too. I will never see my wife's smile ever again."
These cases represent a growing number of patients who developed NAION while using semaglutide medications, often without any warning about this potentially life-altering risk.
Corporate Knowledge and Failure to Warn
Critical questions emerge regarding what Novo Nordisk knew about NAION risks and when they knew it. The EMA's review found that several large studies in type 2 diabetes patients had already suggested that semaglutide use could raise the risk of developing NAION by twofold. Despite this emerging evidence, comprehensive warnings about vision loss were notably absent from product labeling.
The pharmaceutical industry has a legal duty to warn patients about known risks associated with their medications. When companies fail to provide adequate warnings about serious side effects—particularly irreversible conditions like blindness—they may be held liable for resulting injuries.
Regulatory Response: Too Little, Too Late?
While the EMA's action represents important progress, critics argue that regulatory agencies have been slow to respond to mounting evidence. The FDA has not yet issued similar warnings about NAION risks, despite having access to the same concerning data through adverse event reporting systems. Furthermore, NAION lawsuits have been filed in the U.S. against Novo Nordisk.
The regulatory delay is particularly troubling given semaglutide's explosive popularity over the last few years. Studies show that semaglutide prescription fills increased by 442% between January 2021 and December 2023, reaching 2.6 million prescriptions by the end of 2023. Millions of patients have been prescribed these medications without knowledge of potential vision risks.
Legal Implications and Patient Rights
The EMA's formal recognition of NAION as a semaglutide side effect has significant implications for ongoing litigation. Acknowledgment from a regulatory agency like EMA strengthens allegations in Ozempic lawsuits that Novo Nordisk failed to warn patients about serious risks.
Patients who developed NAION while using Ozempic, Wegovy, or Rybelsus are filing lawsuits seeking compensation for:
- Medical expenses and ongoing treatment costs
- Lost wages and diminished earning capacity
- Pain and suffering
- Loss of quality of life
- Disability accommodation costs
Are GLP-1 Drugs Safe?
The NAION revelations are part of a larger pattern of emerging safety concerns with GLP-1 receptor agonists. These medications, initially developed for diabetes management, have become widely prescribed off-label for weight loss despite limited long-term safety data for this indication.
Recent research has identified additional concerning associations, including:
- Increased risk of gallbladder disease
- Potential links to pancreatitis
- Gastrointestinal complications including gastroparesis
- Possible cardiovascular effects
Corporate Leadership Changes Amid Scrutiny
Recent developments have seen significant changes at Novo Nordisk's leadership level. In May 2025, CEO Lars Fruergaard Jørgensen departed from the company amid what Novo described as "recent market challenges." The company's share price had fallen significantly since mid-2024, partly due to increasing competition and emerging safety concerns highlighted in GLP-1 lawsuits.
Moving Forward: What Patients Need to Know
Immediate Action for Current Users
Patients currently using semaglutide medications should:
- Be vigilant for vision changes, particularly sudden, painless vision loss.
- Seek immediate medical attention if any vision problems develop.
- Discuss NAION risks with their healthcare provider.
- Consider alternative treatments if appropriate.
Legal Options for Affected Patients
Individuals who developed NAION while using semaglutide may qualify for a lawsuit. Those who experienced Ozempic side effects should:
- Preserve medical records documenting their diagnosis and treatment.
- Consult with experienced attorneys familiar with pharmaceutical litigation.
- Understand their rights under product liability law by consulting with a lawyer.
- Act promptly to retain legal representation due to statute of limitations requirements.
The Path to Justice and Accountability
The EMA's recognition of NAION as a semaglutide side effect marks a crucial turning point in holding pharmaceutical companies accountable for inadequate safety warnings. This regulatory action validates the experiences of patients who suffered vision loss and strengthens the legal foundation for seeking compensation.
At Wisner Baum, we are committed to helping patients navigate the complex legal landscape surrounding Ozempic and semaglutide injuries. Our experienced team understands the devastating impact of sudden vision loss and works tirelessly to ensure that pharmaceutical companies are held responsible for their failures to warn.
If you or someone in your family developed NAION or other serious complications while using Ozempic, Wegovy, or Rybelsus, you may be entitled to compensation. Contact our office today for a free consultation to discuss your legal options and learn how we can help you seek justice for your injuries.
The fight for pharmaceutical accountability continues, and with each regulatory acknowledgment of previously hidden risks, we move closer to ensuring that patient safety—not corporate profits—remains the top priority in healthcare.
