Overview

• EMA’s safety committee (PRAC) says non‑arteritic anterior ischemic optic neuropathy should be listed as a very rare adverse effect, with formal leaflet updates pending CHMP approval after Spain’s AEMPS warned in June.
• NOIANA can cut blood flow to the optic nerve and cause partial or total vision loss within hours, making it a leading cause of irreversible adult blindness after glaucoma.
• Evidence cited includes a 2024 JAMA Ophthalmology study linking semaglutide to higher NOIANA risk, a February 2025 analysis noting additional maculopathy cases, and a review of 78 trials that found no association with diabetic retinopathy while leaving a possible NOIANA link.
• EMA advises patients to seek immediate medical evaluation for any sudden vision changes and reiterates that the benefits for diabetes control and weight loss still outweigh the risks.
• Real‑world concerns continue with reports of unsupervised sales in Mexico, emerging U.S. class‑action lawsuits over sudden blindness, and pharmacovigilance and observational data noting rare psychiatric adverse‑event signals.