Europe will scrutinize optic nerve ischemia risk among patients of drugs like Ozempic and Wegovy.
The beginning of a high-stakes investigation by European regulators into a connection between non-arteritic anterior ischemic optic neuropathy (NAION) and blockbuster obesity and weight-loss drugs like Ozempic and Wegovy (Novo Nordisk; Bagsværd, Denmark) has officially begun.
The European Medical Association’s Pharmacovigilance Risk Assessment Committee (PRAC) announced the beginning of its investigation into glucagon-like peptide-1 (GLP-1) agonists, also known as semaglutides, at its monthly January meeting.1
The beginning of the formal review came after a December request by the Danish Medicines Agency (DMA) for an investigation into the elevated risk of NAION among semaglutide patients.
The agency’s request was based on data from two observational studies suggesting the connection.2,3
In the announcement, the PRAC also indicated it will look closely at two other observational studies showing a lack of increased risk between NAION.4,5
A LinkedIn post from Singapore-based ophthalmologist Dr. Wei Boon Khor delves deeper into the semaglutide-NAION evidence.
NAION is a rare cause of sight loss induced by reduced blood flow to the eye, resulting in damage to the optic nerve and, in some cases, blindness. Investigators have noted that regardless of a potential semaglutide-NAION causal relationship, the absolute risk involved remains low.
Over the course of the review, the PRAC will consider the entire body of available data on the NAION-semaglutide link, including clinical trials, post-marketing surveillance and research on GLP-1’s mechanism of action.
The PRAC has not given a timeline for the conclusion of the review, with the EMA promising further communication when appropriate.
References
- European Medicines Agency. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC), 13–16 January 2025. European Medicines Agency. Available at: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-january-2025 Accessed on January 22, 2025.
- Grauslund J, Taha AA, Molander LD, et al. Once-weekly semaglutide doubles the five-year risk of nonarteritic anterior ischemic optic neuropathy in a Danish cohort of 424,152 persons with type 2 diabetes. Int J Retina Vitreous. 2024;10(1):97.
- Simonsen E, Lund LC, Thomsen, EM, et al. Use of semaglutide and risk of non-arteritic anterior ischemic optic neuropathy: A Danish–Norwegian cohort study. medRxiv. 2024;24318574
- Chou CC, Pan SY, Sheen YJ, et al. Association between Semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy: A Multinational Population-Based Study. Ophthalmology. 2024;S0161-6420(24)00685-7.
- Klonoff DC, Hui G, Gombar S. Real-World Evidence Assessment of the Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide. J Diabetes Sci Technol. 2024;18(6):1517-1518.