
Following the publication of two research papers from the University of Southern Denmark (SDU) suggesting that Ozempic use may increase the risk of a rare eye condition, the Danish Medicines Agency has requested a formal investigation by European authorities.
According to a statement, the Danish Medicines Agency has recorded 19 cases of nonarteritic anterior ischemic optic neuropathy (NAION) across Denmark. The first report identifying NAION as a potential adverse reaction to semaglutide—the active ingredient in Ozempic and Novo’s Wegovy—was filed in July.
NAION occurs when blood flow to the optic nerve is disrupted, causing nerve damage and sudden vision loss in one eye. It most commonly affects individuals aged 50 and older.
The Danish drug regulator has asked the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee to review the data.
“After a thorough evaluation of the studies from the University of Southern Denmark and Novo Nordisk’s internal safety assessment, Novo Nordisk is of the opinion that the benefit-risk profile of semaglutide remains unchanged,” a company spokesperson said via email.
The new findings follow a July study published in JAMA Ophthalmology, which analyzed 16,827 individuals. The study found that patients using Ozempic had a higher risk of developing NAION compared to those taking non-GLP-1 medications for diabetes or obesity.
Harvard researchers conducting the observational study noted a potential link between semaglutide and NAION, while emphasizing the need for further research to establish causation.
One of the recent studies, conducted in Denmark and Norway, concluded that semaglutide use is associated with an increased risk of NAION, although the additional absolute risk is minimal.
In another trial, researchers examined data from nearly 425,000 diabetic patients. Among these, 106,454 were prescribed Ozempic, while the rest were given other diabetes medications. Results showed that two individuals per 10,000 using semaglutide developed NAION, compared to one per 10,000 in the control group.
The Danish Medicines Agency noted that earlier reports and studies on NAION lacked sufficient evidence to establish a connection between the medication and the condition. However, the SDU findings support the suspicion and may provide critical information for further evaluation.
A Novo Nordisk spokesperson stated that the company conducted its own analysis of randomized controlled clinical trials involving GLP-1 receptor agonists. This included a blinded review by ophthalmologists to confirm NAION diagnoses. The analysis found very few confirmed cases of NAION, with no indication of an imbalance unfavorable to Novo Nordisk’s GLP-1 receptor agonists.