Australia's Therapeutics Goods Administration (TGA) Issues Class-Wide GLP-1 Receptor Agonist Product Warning Update on July 25, 2026 for Non-Arteritic Anterior Ischaemic Optic Neuropathy (NAION), Adding Label Language Across Trulicity (Dulaglutide), Ozempic (Semaglutide), Wegovy (Semaglutide), Mounjaro (Tirzepatide), and Saxenda (Liraglutide) After the Advisory Committee on Medicines Concluded the Current Evidence Supports the Signal for Semaglutide but Not for Dulaglutide or Tirzepatide; 36 Total Cases of Optic Ischaemic Neuropathy Reported to the Australian Database of Adverse Event Notifications (DAEN) Including 23 for Semaglutide, 10 for Tirzepatide, and 3 for Liraglutide, With Patient Guidance to Seek Urgent Medical Attention for Sudden Vision Loss
Australia's Therapeutics Goods Administration (TGA) issued a class-wide product warning update Saturday July 25, 2026 for GLP-1 receptor agonists on non-arteritic anterior ischaemic optic neuropathy (NAION), a rare but severe form of eye disorder that may result in permanent visual impairment including blindness. No treatment has been shown to improve visual acuity outcomes after NAION onset. The label update applies across all five GLP-1 RA products currently marketed in Australia: Trulicity (dulaglutide, Eli Lilly), Ozempic (semaglutide, Novo Nordisk), Wegovy (semaglutide, Novo Nordisk), Mounjaro (tirzepatide, Eli Lilly), and Saxenda (liraglutide, Novo Nordisk). The Advisory Committee on Medicines concluded that the current evidence supports the signal for semaglutide but not for dulaglutide or tirzepatide. A search of the Australian Database of Adverse Event Notifications (DAEN) found 36 cases of optic ischaemic neuropathy with GLP-1 RAs, including 23 for semaglutide, 10 for tirzepatide, and 3 for liraglutide. Patient guidance advises seeking urgent medical attention for any sudden vision loss including partial loss of vision. The Australian action follows the UK MHRA Drug Safety Update on semaglutide and NAION issued February 5, 2026.