Overview

• The EMA’s safety committee (PRAC) recommended adding non-arteritic anterior ischemic optic neuropathy to semaglutide product information as a very rare adverse reaction.
• The estimated frequency is about 1 in 10,000 patients (roughly 0.04%), and doctors advise immediate evaluation for any sudden changes in vision.
• The labeling update now awaits formal adoption by the CHMP, after Spain’s AEMPS issued a national alert in June.
• The EMA states the overall benefit–risk profile for diabetes control and weight loss remains favorable, with continued clinical vigilance advised.
• Separate reports continue to flag psychiatric adverse-event signals and highlight unsupervised access reported in some Mexican pharmacies, reinforcing calls for careful medical oversight.