COPENHAGEN (Reuters) – The Danish Medicines Agency announced on Monday that it would refer the European Union’s pharmacovigilance committee to examine the results of two Danish studies associating Novo Nordisk’s drug Ozempic with a rare eye condition.
The two studies conducted by the University of Southern Denmark (SDU) show that Ozempic more than doubles the risk of NAION (non-arteritic anterior ischemic optic neuropathy) in type 2 diabetics.
The Danish Medicines Agency has asked the European Pharmacovigilance Risk Assessment Committee (PRAC) to take these data into account.
Novo Nordisk responded by stating that “after a thorough evaluation of the studies, Novo Nordisk believes that the benefit-risk profile of semaglutide remains unchanged”, adding that patient safety remains a priority.
According to SDU professor Jakob Grauslund, the number of NAION cases in Denmark has increased since the introduction of Ozempic in 2018.
The Danish studies focused on the effect of semaglutide, present in Ozempic, a drug in the GLP-1 receptor agonist class.
NAION is an irreversible disease caused by insufficient blood supply to the optic nerve, leading to sudden vision loss.
(Written by Isabelle Yr Carlsson, Noémie Naudin, edited by Sophie Louet)
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