EMA’s safety committee (PRAC) has concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION), an eye condition that may cause loss of vision. After reviewing all available data on NAION with semaglutide, including data from non-clinical studies, clinical trials, post-marketing surveillance and the medical literature, PRAC has concluded that NAION is a very rare side effect of semaglutide (meaning it may affect up to 1 in 10,000 people taking semaglutide). Results from several large epidemiological studies suggest that exposure to semaglutide in adults with type 2 diabetes is associated with an approximately two-fold increase in the risk of developing NAION compared with people not taking the medicine.

"As of November 11, 2024, FAERS reports a total 16,662 serious events and 505 patient deaths associated with semaglutide." It notes that these are adverse event reports in the FDA Adverse Event Reporting System (FAERS), and that "FAERS does not indicate that the compounded drug caused the death, only that the patient was reported to have been" taking semaglutide at the time. For compounded semaglutide, FAERS shows "496 adverse events reports, 378 identified as serious, and of those, 11 indicate a patient died while taking compounded semaglutide."

EMA’s safety committee (PRAC) has concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non‑arteritic anterior ischemic optic neuropathy (NAION), an eye condition that may cause loss of vision. After reviewing all available data on NAION with semaglutide, including data from non‑clinical studies, clinical trials, post‑marketing surveillance and the medical literature, PRAC has concluded that NAION is a very rare side effect of semaglutide (meaning it may affect up to 1 in 10,000 people taking semaglutide). EMA has therefore recommended that the product information for semaglutide medicines is updated to include NAION as a side effect with a frequency of ‘very rare’. If patients experience a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, they should contact their doctor without delay; if NAION is confirmed, treatment with semaglutide should be stopped.

Healthcare professionals and researchers have reported a concerning correlation between the use of Ozempic and the development of non-arteritic anterior ischemic optic neuropathy (NAION), a rare but potentially serious eye condition that, if untreated, may result in irreversible vision loss with no proven permanent treatment actually exists. A retrospective cohort study involving 16,827 neuro-ophthalmology patients found that over 36 months, the cumulative incidence of NAION was 8.9% in diabetic patients taking semaglutide compared to 1.8% in those using other antidiabetic agents (HR 4.28, 95% CI 1.62–11.29). In overweight or obese patients, the rates were 6.7% versus 0.8% (HR 7.64, 95% CI 2.21–26.36). However, these numbers represent a 3-year cumulative event rate in a specialized clinical group, not the overall annual incidence in the general population, which stays around 2 to 10 cases per 100,000 each year.

Through signal detection methods, the study identified serious retinal complications, such as non-arteritic anterior ischemic optic neuropathy (NAION) and retinal hemorrhage, that were significantly linked to specific dosage forms. Notably, serious outcomes such as blindness were reported in 4.98% of all Rybelsus (oral form) cases and 4.28% of Wegovy and/or Ozempic (injectable forms) cases. Among the subcutaneous preferred terms, the most notable included cataract (6.08%), diabetic retinopathy (4.71%), and blindness (4.28%).

This pharmacovigilance study analyzed the FDA Adverse Event Reporting System (FAERS) database from 2017 Q4 to 2023 Q4 and "a total of 22,287 adverse reaction records related to semaglutide were identified." It reports that adverse events for semaglutide included gastrointestinal disorders, blurred vision, diabetic retinopathy, acute renal injury, and hospitalization. The authors note that "these adverse reactions are also explicitly warned about in the product labeling" of semaglutide products.

The FDA describes FAERS as a database used to identify "potential signals of serious risks/new safety information" for drugs. In the July–September 2023 listing, the agency includes "Glucagon-like peptide-1 (GLP-1) receptor agonists" with product names such as "Ozempic (semaglutide), Rybelsus (semaglutide), Wegovy (semaglutide)" among others. It notes that the "Adverse Reactions" section of the labeling for several GLP-1 products, including Ozempic and Rybelsus, "was updated between December 2024 and May 2025 to include alopecia."

The FDA reports that it "has received reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products." Reported overdose-related adverse events include "gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache." The agency encourages reporting of adverse events and medication errors associated with compounded semaglutide products to FDA’s MedWatch program.

Semaglutide, marketed as Ozempic, Wegovy and Rybelsus, has largely been considered safe and effective, but its rapid uptake has led to increased scrutiny of rare adverse effects. Until now, various studies have shown the negative impact of these drugs, mainly because of gastrointestinal disorders (pancreatitis, nausea, vomiting, etc.), renal failure, liver injury, allergic reactions etc. We also investigated the occurrence of adverse drug reactions (ADRs) by searching the EudraVigilance database (EV) for Individual Case Safety Reports (ICSRs). Semaglutide presented the lowest number of severe ADRs but the highest number of ICSRs reported in EV, and no unexpected safety issues have been reported for it until now.

This study, based on medical registry data, reported an increased absolute risk of NAION of 7.5% in patients with T2DM and 7% in individuals using a semaglutide regimen for weight loss. In a registry-based prospective cohort study identifying 424,152 patients diagnosed with type 2 diabetes in Denmark between December 1, 2018 and December 31, 2023, 106,454 of these patients were exposed to semaglutide and 67 developed NAION. The study concluded use of semaglutide more than doubles the risk of NAION, even when multiple other factors have been taken into account.

A small study published in JAMA Ophthalmology analyzed data from nine patients who developed severe vision issues, including sudden blindness, while taking semaglutide (Wegovy, Ozempic) or tirzepatide (Mounjaro, Zepbound). Of those participants, seven developed a condition called non-arteritic ischemic anterior optic neuropathy (NAION, which is sudden vision loss due to lack of blood flow to the optic nerve, and is usually permanent), one developed bilateral papillitis and another paracentral acute middle maculopathy. The researchers noted that this study does not prove causation but raises concerns about a possible link between these weight loss drugs and serious eye problems.

Using FAERS data (2005 Q2–2024 Q3), this study identified neurological adverse events associated with GLP-1 receptor agonists. It notes that "Wernicke encephalopathy, a life-threatening complication of thiamine deficiency characterized by ophthalmoparesis, ataxia, confusion, and nystagmus, has been reported in patients using semaglutide." It also mentions that rare neuro-ophthalmic events such as "ophthalmic migraine" related to this class "warrant monitoring despite low incidence." The authors emphasize that the observed associations "do not establish causality" but highlight the need for vigilance.

During its January 2025 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) started a review of medicines containing semaglutide following concerns regarding an increased risk of non‑arteritic anterior ischemic optic neuropathy (NAION). NAION is a disorder caused by reduced blood flow to the optic nerve in the eye with potential damage to the nerve, which can lead to loss of vision in the affected eye. The PRAC will now review all available data on NAION with semaglutide including data from clinical trials, post‑marketing surveillance, studies on the mechanism of action and the medical literature (including the results of the observational studies).

Ozempic blindness isn’t a real diagnosis. It’s a nickname used to describe sudden vision loss that may be linked to the weight loss drugs semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound). After taking a look at current research, the European Medicines Agency said NAION may affect up to 1 in 10,000 people taking semaglutide. Some studies show a possible link between these drugs and eye issues like NAION, but the risk is very low and most people who take them will not have vision changes.

This pharmacovigilance study of GLP-1 receptor agonists using FAERS notes that from January 2018 to December 2022 "a total of 31,439 adverse event reports (AERs) involving the selected molecules were submitted to FAERS, being the most represented: dulaglutide (37.6%), semaglutide (26.1%), and liraglutide (25.0%)." It reports that for semaglutide, there was an increase in the number of reported AERs compared to other GLP-1 analogues, and that "drug misuse-, abuse-, and withdrawal-related AERs were most typically reported for semaglutide" with elevated proportional reporting ratios for terms such as "drug abuse" and "drug withdrawal syndrome."

In this analysis of the FDA Adverse Event Reporting System (FAERS), the authors examined "drug misuse-, abuse-, and withdrawal-related AERs" for semaglutide and other GLP-1 receptor agonists from January 2018 to December 2022. They report that among 31,439 AERs for selected molecules, semaglutide accounted for 26.1% of reports. The study found that misuse-related terms such as "drug abuse", "drug withdrawal syndrome", and "prescription drug used without a prescription" were reported more than 3.5 times as frequently for semaglutide compared to other GLP-1 analogues, suggesting "a potential misuse of semaglutide, warranting additional in-depth research."

Most viewed this week from JAMA Ophthalmology: This retrospective case series reports ophthalmic complications, including nonarteritic ischemic anterior optic neuropathy and bilateral papillitis, in patients using semaglutide or tirzepatide. Of the seven patients with NAION, three had typical cases, with unilateral vision loss upon waking, optic nerve swelling and characteristic visual field defects. This case series adds to emerging evidence that GLP-1 receptor agonists such as semaglutide may be associated with rare but serious vision problems, including NAION that can lead to permanent visual impairment.

Emerging research from around the world shows that the active ingredient in both, however, may be linked to sudden blindness. Researchers have observed that patients prescribed semaglutide, the active ingredient in both drugs, had an increased risk of nonarteritic anterior ischemic optic neuropathy (NAION). NAION is a disease of the optic nerve that causes blindness. After reviewing records of about 37 million adults, they reported a small increase of NAION risk in patients with type 2 diabetes who took semaglutide.

This study of GLP-1 receptor agonists using FAERS reports that "semaglutide showed a moderate suicide-related adverse events signal in the weight loss population (ROR 2.55, 95% CI 1.97–3.31)." It also notes that "sensory nerve abnormalities were associated with dulaglutide, liraglutide, semaglutide, and tirzepatide, and among these drugs, semaglutide showed the strongest signal (ROR 5.05, 95% CI 4.30–5.94) and the most significant number of reports (N = 197)." The authors conclude that semaglutide had a relatively higher proportion of neuropsychiatric adverse events and "positive and the strongest signals" across a range of neuropsychiatric abnormalities.

Nonarteritic anterior ischemic optic neuropathy (NAION), which can lead to vision loss, is a “very rare” side effect of treatment with the glucagon‑like peptide‑1 (GLP‑1) receptor agonist semaglutide, the safety committee of the European Medicines Agency (EMA) has concluded. The agency’s pharmacovigilance risk assessment committee (PRAC) determined that up to one out of every 10,000 people taking semaglutide—sold under trade names Ozempic, Rybelsus, and Wegovy for the treatment of diabetes and obesity—may be affected by NAION. The eye condition is caused by a reduction in blood flow to the optic nerve, eventually resulting in nerve damage and possibly blindness; EMA has recommended updating semaglutide’s labeling to reflect this information and advised that treatment should be stopped if NAION is diagnosed.

Can semaglutides cause blindness? Some studies suggest there may be a connection between semaglutide use and increased risk for a blinding eye disease called non-arteritic anterior ischemic optic neuropathy (NAION). But experts say there isn't enough data yet to suggest patients should be concerned or should stop taking their medications. "It is premature to conclude that the association is a causal association. More research is necessary to test the hypothesis," the American Academy of Ophthalmology notes.

A potentially blinding condition is a very rare side effect of the GLP‑1 receptor agonist semaglutide (Ozempic, Wegovy, Rybelsus), the European Medicines Agency (EMA) has concluded. The eye condition, called non‑arteritic anterior ischemic optic neuropathy (NAION), can cause sudden, painless vision loss in one eye, and may lead to permanent visual impairment. EMA said results from several large epidemiological studies suggested that exposure to semaglutide in adults with type 2 diabetes was associated with an approximately twofold increase in the risk of developing NAION compared with people not taking the medicine, corresponding to about one additional case per 10,000 person‑years of treatment.

This pharmacovigilance study describes FAERS as "a publicly accessible centralized repository for reports of adverse events associated with FDA-approved drugs." It analyzes mortality and serious adverse events for GLP-1 receptor agonists, including semaglutide-containing products such as Ozempic and Wegovy, although detailed counts for each brand are not provided in the abstract. The authors use FAERS case reports to estimate proportions of reported serious outcomes, but they caution that FAERS data cannot establish incidence or causality.

The EMA’s safety committee has issued a warning that the GLP‑1 receptor agonist Ozempic (semaglutide, Novo Nordisk A/S) can cause an acute eye condition in which the optic nerve is damaged by a sudden loss of blood supply. After reviewing several large epidemiological studies, clinical trial and in‑market data, EMA’s Pharmacovigilance Risk Assessment Committee has concluded non‑arteritic anterior ischemic optic neuropathy is a “very rare” side effect of Ozempic, that “may affect up to one in 10,000 people taking semaglutide.” EMA has recommended updating the product information for semaglutide medicines to include NAION and advised patients to contact their doctor without delay if they experience sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide.

The case reports occurrence of sequential NAION in a patient with weight loss on semaglutide. Case Presentation: A 73-year-old man with a history of type 2 diabetes, obesity, and hypertension experienced bilateral non-arteritic anterior ischemic optic neuropathy after significant weight reduction and associated postural hypotension on semaglutide. Conclusion: This case report highlights the importance of considering NA-AION as a possible adverse effect of semaglutide use, particularly in patients with preexisting risk factors for optic nerve ischaemia.

Clinical studies have demonstrated its effectiveness for these purposes but have also documented vision changes that can occur in some patients, including blurred vision, worsening diabetic retinopathy and macular complications. One study also suggested there could be a connection between semaglutide use and increased risk for non-arteritic anterior ischemic optic neuropathy (NAION), a blinding eye disease. However, leading eye physicians, including the American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society, believe more research on this topic is needed, and there isn’t enough data to suggest patients should be concerned about this finding or stop taking semaglutide.

Until now, various studies have shown the negative impact of these drugs, mainly because of gastrointestinal disorders (pancreatitis, nausea, vomiting, etc.), renal failure, liver injury, allergic reactions etc. According to data published in EudraVigilance, adverse drug reactions reported in the group of patients treated with semaglutide included serious events such as renal failure and liver injury, but the proportion of ADRs reported from total cases treated with semaglutide (1.99%) was less than for the group of all other GLP‑1 receptor agonists (2.08%). Even though semaglutide had the highest number of individual case safety reports in EudraVigilance, the analysis concluded that no unexpected safety issues had been reported for it until now.

Recent scientific research has revealed alarming connections between this popular drug and serious vision problems that can lead to permanent blindness. The emergence of non-arteritic anterior ischemic optic neuropathy (NAION) cases among Ozempic users has prompted widespread concern and legal action against manufacturer Novo Nordisk. Researchers discovered that diabetic patients taking semaglutide faced a four-fold increased risk of developing NAION, while those using it for weight management experienced an even more alarming seven-fold increase in risk. This type of optic nerve damage often results in permanent, irreversible vision loss.

Ozempic use can lead to severe eye problems, including blindness. This may be caused by conditions like non-arteritic anterior ischemic optic neuropathy (NAION). A FAERS review for NAION examined 302,706 reports from the FAERS database. The study concluded that of the 11,558 reports for semaglutide, 417 reported visual impairment or ischemic optic neuropathy (ION). Research has highlighted potential dangers of semaglutide, including eye problems like aggravated diabetic retinopathy, blindness, blurred vision, NAION, vision changes and macular concerns.

The authors determined there is substantial numerical evidence of a higher risk of NAION in patients exposed to semaglutide compared to patients taking alternative medications for treatment of type 2 diabetes and obesity. In a registry-based prospective cohort study identifying 424,152 patients diagnosed with type 2 diabetes in Denmark between December 1, 2018 and December 31, 2023, 106,454 of these patients were exposed to semaglutide and 67 developed NAION. The study concluded use of semaglutide more than doubles the risk of NAION, even when multiple other factors have been taken into account. NAION is a devastating ocular condition causing permanent vision loss; the end result is blindness when the optic nerve does not receive the nutrients and oxygen it needs.

TorHoerman Law is reviewing claims involving NAION, sudden vision loss, and other serious eye injuries allegedly associated with Ozempic, Wegovy, Rybelsus, and other semaglutide medications. Recent studies have raised concerns about a potential link between Ozempic (semaglutide) and serious vision problems, particularly the rare condition known as non-arteritic anterior ischemic optic neuropathy (NAION). The optic nerve damage in NAION is typically irreversible, and the condition has been linked to the use of GLP-1 receptor agonists like Ozempic. According to research published by a team from Massachusetts Eye and Ear, patients who took Ozempic or Wegovy for weight loss were seven times more likely to experience NAION than those on other obesity treatments; in the diabetes group, patients on semaglutide had a fourfold increased risk.

Semaglutide, the active ingredient in Ozempic and Wegovy, has been linked to an increased risk of stroke within the eye, raising significant concerns for those taking this medication. The new research is concerning because it shows a heightened risk for patients developing a serious blinding eye condition called NAION. This study, recently published in JAMA Ophthalmology, found a statistically significant increase in the risk of developing NAION for patients taking semaglutide, which includes both Ozempic and Wegovy.

The GLP-1 NAION Lawsuit is an active multidistrict litigation. If you or a loved one used a GLP-1 medication like Ozempic or Wegovy and suffered sudden vision loss, blindness, or a diagnosis of non-arteritic anterior ischemic optic neuropathy (NAION), you may be eligible to file a claim. The lawsuits generally allege that manufacturers failed to adequately warn about the risk of NAION and related severe eye injuries, which can result in permanent vision loss or blindness. Plaintiffs report sudden, severe vision changes occurring while using GLP-1 drugs, and are seeking compensation for medical bills, lost wages, and pain and suffering associated with irreversible eye damage.

Non-arteritic anterior ischemic optic neuropathy (NAION) is a rare eye condition that can lead to incurable blindness in one eye. Semaglutide is the active ingredient in both Ozempic and Wegovy. It has been linked to an increased risk of developing NAION, a condition that leads to incurable blindness in one eye. Semaglutide use resulted in much higher reporting of vision injury than use of other GLP-1 receptor agonist drugs used for diabetes and weight loss, based on analysis of FAERS data.

The EMA has concluded that non‑arteritic anterior ischemic optic neuropathy (NAION), a potentially blinding condition, is a very rare side effect of the GLP‑1 receptor agonist semaglutide (Ozempic, Wegovy, Rybelsus). According to the EMA communication shared here, NAION may affect up to 1 in 10,000 people taking semaglutide, based on a review of clinical trials, postmarketing surveillance data, and epidemiological studies. Patients are advised to seek medical attention urgently if they experience sudden loss of vision or rapidly worsening eyesight while on semaglutide therapy.