PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy

EMA’s safety committee (PRAC) has concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION), an eye condition that may cause loss of vision. Semaglutide, a GLP-1 receptor agonist, is the active substance in certain medicines used in the treatment of diabetes and obesity (namely Ozempic, Rybelsus and Wegovy). After reviewing all available data on NAION with semaglutide, including data from non-clinical studies, clinical trials, post-marketing surveillance and the medical literature, PRAC has concluded that NAION is a very rare side effect of semaglutide (meaning it may affect up to 1 in 10,000 people taking semaglutide). Results from several large epidemiological studies suggest 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 people not taking the medicine. This corresponds to 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. Data from clinical trials also point to a slightly higher risk of developing the condition in people taking semaglutide, compared with people taking placebo (a dummy treatment). EMA has therefore recommended that the product information for semaglutide medicines is updated to include NAION as a side effect with a...