Recent studies have established a concerning link between Ozempic, a widely used medication for type-2 diabetes, and a rare eye condition known as non-arteritic anterior ischemic optic neuropathy (NAION). This revelation marks the first instance where a regulatory body has officially confirmed this potential side effect associated with semaglutide, the active ingredient in both Ozempic and Wegovy, as well as Novo Nordisk's diabetes medication Rybelsus.
The European Medicines Agency (EMA) has indicated that the incidence of NAION among patients using semaglutide may be as high as 1 in 10,000 individuals over a treatment period of at least one year. This condition is recognized as the second-most prevalent cause of blindness resulting from optic nerve damage, following glaucoma. The clinical community has been aware of this potential risk for some time, and according to Barclays analyst Emily Field, this new information is unlikely to significantly alter prescribing habits among healthcare professionals.
In early trading, shares of the Danish pharmaceutical company Novo Nordisk experienced a nearly 2.5% increase, reflecting a positive market reaction despite the concerning news. The EMA commenced its review of semaglutide in December, ultimately recommending that Novo Nordisk update the product information for its drugs to include NAION as a very rare side effect. In response, Novo has committed to collaborating with the EMA on revising the labels, asserting that clinical trials and post-market studies have not indicated a plausible risk of the drugs causing NAION.
Despite the emergence of this potential risk, Novo Nordisk has stated that the overall benefit-risk profile of semaglutide remains favorable. The company is currently facing scrutiny from investors who are worried about losing its competitive edge in the rapidly evolving obesity treatment market. This tension led to the dismissal of CEO Lars Fruergaard Jorgensen in May, highlighting the challenges the company is navigating.
The EMA's findings are underscored by several large-scale studies involving type-2 diabetes patients, which suggest that the use of Novo's medications could potentially double the risk of developing NAION. A significant study published in March, which analyzed nearly 350,000 diabetes patients, found that the likelihood of developing NAION more than doubled after two years of treatment with Ozempic, in contrast to patients using alternative medication classes.
As the situation develops, the U.S. Department of Health and Human Services has yet to respond to inquiries regarding whether the Food and Drug Administration (FDA) is conducting its own investigation into the reported side effects of semaglutide. The ongoing discourse around NAION and Ozempic underscores the importance of continuous monitoring and evaluation of medications used in the treatment of type-2 diabetes.
Reporting by Manas Mishra and Mariam Sunny in Bengaluru; Edited by Shilpi Majumdar.
