The European Medicines Agency is to update the side effect profile for semaglutide following evidence from epidemiological studies that use of the drug is associated with a very rare eye condition known as non-arteritic anterior ischaemic optic neuropathy (NAION). This may cause loss of vision. The decision was announced on 6 June and will affect the labelling of three approved semaglutide products, Ozempic, Rybelsus and Wegovy. All three are produced by Novo Nordisk A/S and are on the market in the EU. The drugs have also been approved by the US Food and Drug Administration which is reportedly studying the safety data but has not issued a warning.
Semaglutide is a medicine that mimics the effects of the incretin hormone glucagon-like peptide-1 which helps regulate blood sugar levels and appetite. The EMA said its review suggested that exposure to semaglutide in adults with type 2 diabetes is associated with an approximately two-fold increase in the risk of developing NAION compared with non-use. This corresponds with approximately one additional case of NAION per 10,000 person-years of treatment. One person-year corresponds to one person taking semaglutide for one year. The updated label will identify the side effect with a frequency label of ‘very rare,’ the agency said.
Copyright 2025 Evernow Publishing Ltd