Semaglutide NAION Risk: EMA Review Initiated Amid Conflicting Evidence

By João L. Carapinha

January 21, 2025

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the potential semaglutide NAION risk associated with medicines containing semaglutide. This rare eye condition, known as non-arteritic anterior ischemic optic neuropathy (NAION), has drawn attention due to conflicting findings from recent observational studies regarding its risk in patients treated with semaglutide, which doctors commonly prescribe for diabetes and obesity.

Quick Overview

Risk Assessment. PRAC is evaluating the association between NAION and semaglutide-containing medicines, including Ozempic, Rybelsus, and Wegovy.
Conflicting Studies. Recent observational studies present conflicting evidence concerning the increased risk of NAION in these patients.
Data Review. The committee will analyze all available data, including clinical trials, post-marketing surveillance, mechanistic studies, and relevant medical literature.
Patient Population. Individuals with type 2 diabetes may have an inherent risk of developing NAION, complicating assessment of the semaglutide NAION risk.

Background

PRAC is tasked with comprehensive risk management of human medicines. This includes the detection, assessment, minimization, and communication of adverse reaction risks, as set forth by the EMA. Safety signals like the potential link between semaglutide and NAION arise from various sources, including spontaneous reports and clinical studies. These signals necessitate further investigation to ascertain any new or previously unrecognized associations between a medicine and adverse events. The EMA performs post-authorisation safety studies (PASSs) to collect additional safety information about approved medicines. These studies are relevant to the ongoing evaluation of semaglutide.

Implications

The potential connection between semaglutide and NAION could significantly impact the health outcomes of patients using these medications. NAION may result in vision loss, which poses a serious concern that requires careful management. Should the review indicate an increased risk of NAION, this may lead to updates in risk management plans (RMPs) and product information, ensuring healthcare providers and patients are well-informed and protected. Alterations in the safety profile of semaglutide-containing medicines could affect their cost-effectiveness and overall benefit-risk balance. Such changes might influence prescribing habits, healthcare resource allocation, and patient access to these therapies.

Reference url

Recent Posts

Datroway TNBC Therapy: Transforming First-Line Treatment for Metastatic Triple-Negative Breast Ca...

By João L. Carapinha

October 13, 2025

Datroway TNBC therapy (datopotamab deruxtecan) has demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) as a first-line treatment compared to chemotherapy in patients with metastatic triple-negative breast cance...
Evolving Burden of Obesity in the US: Key Insights on Obesity Prevention Strategies

By HEOR Staff Writer

October 10, 2025

What are the most effective obesity prevention strategies for reducing long-term healthcare and societal costs in the United States? Recent advanced population models reveal that focusing on early, targeted obesity prevention strategies offers far greater value to health systems and society than ...
Simponi Pediatric Approval: FDA Grants First Pediatric Indication for Ulcerative Colitis Treatment

By HEOR Staff Writer

October 9, 2025

The U.S. Food and Drug Administration has granted Simponi pediatric approval for Johnson & Johnson's Simponi (golimumab), which is intended for children with moderately to severely active ulcerative colitis who weigh at least 15 kg. This historic approval is backed by data from the PURSUIT pr...