EMA flags rare vision risk with Semaglutide- a active substance in Ozempic, Rybelsus, Wegovy

EMA has therefore recommended that the product information for semaglutide medicines is updated to include NAION as a side effect with a frequency of ‘very rare’. If patients experience a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, they should contact their doctor without delay. If NAION is confirmed, treatment with semaglutide should be stopped.

More about the procedure

The potential association between exposure to semaglutide and NAION (non-arteritic anterior ischemic optic neuropathy) was evaluated as part of a post-authorisation measure (LEG) resulting from a PSUR assessment.

The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations.

The PRAC recommendations will now be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States in due course.