During its January 2025 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) started a review of medicines containing semaglutide following concerns regarding an increased risk of non-arteritic anterior ischemic optic neuropathy (NAION).
Medicines containing semaglutide
The Pharmacovigilance Risk Assessment Committee (PRAC) will assess risk of non-arteritic anterior ischemic optic neuropathy (NAION). The PRAC started a review of medicines containing semaglutide following concerns regarding an increased risk of developing NAION, a rare eye condition, as suggested in two recent observational studies, while two other recent observational studies do not suggest an increased risk.
Semaglutide, a GLP-1 receptor agonist, is the active substance in certain medicines used in the treatment of diabetes and obesity.
The PRAC is assessing whether patients treated with semaglutide may have an elevated risk of developing NAION. This is a disorder caused by reduced blood flow to the optic nerve in the eye with potential damage to the nerve, which can lead to loss of vision in the affected eye. Patients with type 2 diabetes might already have an inherently higher risk of developing this condition.
The PRAC will now review all available data on NAION with semaglutide including data from clinical trials, post-marketing surveillance, studies on the mechanism of action and the medical literature (including the results of the observational studies).
EMA will communicate further when appropriate.
In Belgium, medicines containing semaglutide are authorised and marketed under the following names:
- Ozempic;
- Rybelsus.
More information is available on the EMA website.