EMA says Ozempic, Wegovy may cause rare eye condition
Investing.com -- The European Medicines Agency's (EMA) safety committee, PRAC, said Friday that it has concluded that Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), a rare eye condition that can lead to vision loss, is a "very rare side effect" of semaglutide medicines, including Ozempic, Rybelsus, and Wegovy.
The medications, owned by Novo Nordisk (NYSE:NVO), are widely used for the treatment of diabetes and obesity.
Following a comprehensive review of all available data, including non-clinical studies, clinical trials, post-marketing surveillance, and medical literature, PRAC determined that NAION "may affect up to 1 in 10,000 people taking semaglutide."
The firm explained that several large epidemiological studies indicate that adults with type 2 diabetes taking semaglutide face "an approximately two-fold increase in the risk of developing NAION" compared to those not on the medication.
This is said to translate to about "one additional case of NAION per 10,000 person-years of treatment."
The EMA added that clinical trial data also pointed to a "slightly higher risk" for those on semaglutide versus placebo.
As a result, the EMA said it has recommended updating the product information for semaglutide medicines to include NAION as a "very rare" side effect.
They conclude that patients experiencing "a sudden loss of vision or rapidly worsening eyesight" while on semaglutide are advised to contact their doctor immediately.
If NAION is confirmed, "treatment with semaglutide should be stopped,' states the EMA.
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Those who had only taken their medication for 6–18 months actually had a slightly lower risk than those who didn't take the medication. However, at the 18–30 month mark, GLP-1 users' risk of developing wet AMD more than doubled compared to non-users. And those taking the drugs for 30 months or longer had more than triple the risk. 'This was definitely surprising, especially given the growing enthusiasm for GLP-1 receptor agonists for their cardiovascular and metabolic benefits. It really highlights the need for further investigation into their ocular safety profile,' first study author Reut Shor, MD, of the Department of Ophthalmology and Vision Sciences at the University of Toronto, Canada, told Healthline. Despite the increase in risk, the absolute risk of developing wet AMD was still low: 0.2% among those taking a GLP-1 and 0.1% among those who didn't. Do GLP-1 drugs harm eye health? While not definitive, the study raises further questions about the potential risks posed by GLP-1 drugs for eye health. Prior studies have also identified links between GLP-1s and other forms of eye disease in people with type 2 diabetes. In a major phase 3 semaglutide trial in 2016, researchers identified that type 2 diabetes patients taking semaglutide had a higher risk of complications of diabetic retinopathy compared to a placebo. Those findings were published in The New England Journal of Medicine. However, other studies have provided conflicting evidence. A retrospective 2024 study evaluated nearly 700 subjects with type 2 diabetes who were taking a GLP-1 drug and found no association between GLP-1s and worsening retinopathy. Also in 2024, researchers found that patients with type 2 diabetes who were prescribed semaglutide were at greater risk of NAION compared to those who weren't. NAION is a condition that causes sudden blindness, typically just in one eye, due to a lack of blood flow to the optic nerve. The mechanism for why GLP-1 drug use may lead to wet AMD is not well established, but a predominant theory is that lowering blood sugar rapidly leads to a lack of oxygen in the retina. 'When you make the retina more hypoxic, which is what the GLP-1s do, it basically pushes it further over the threshold, causing more abnormal blood vessels to grow,' said Linda Lam, MD, MBA, an ophthalmologist with Keck Medicine of USC, who wasn't involved in the research. Abnormal blood vessel growth in the eye is the hallmark of wet AMD. While GLP-1s offer many health benefits, eye disease risk must be considered in some populations, Lam told Healthline. 'In this particular group of patients who are older, who are diabetics, I really would caution against the extended use of GLP-1s,' she said. Lam reiterated the importance of annual eye exams for the general population, but in particular for those with diabetes, to identify and diagnose eye disease early on. People with type 2 diabetes, especially those taking a GLP-1 drug, should be aware of the signs and symptoms of vision loss and consult with their doctor immediately. These include:
