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Ozempic & NAION: EU Safety Panel Continues Probe Into Link With Eye Condition

 
• By Neena Brizmohun

The European Medicines Agency says it will take appropriate measures to update the Ozempic’s package leaflet if new evidence arises.

Female hands holding an insulin pen. Ozempic Insulin injection pen or insulin cartridge pen for diabetics
The EMA is investigating whether Ozempic increases the risk of developing a rare eye condition (Shutterstock)
Key Takeaways
  • The European Medicines Agency’s assessment of whether patients treated with Ozempic (semaglutide) may have an elevated risk of developing non-arteritic anterior ischemic optic neuropathy (NAION) is being conducted within the latest periodic safety update report (PSUR) for the drug, as part of the ongoing safety monitoring.
  • The assessment will include findings from the US registry that first found a potential link between the drug and NAION, as well as data from two more recent Danish studies that found that Ozempic more than doubled the risk of NAION.
  • Novo Nordisk maintains that the benefit-risk profile of semaglutide remains unchanged.


The European Medicines Agency is continuing to investigate whether patients treated with Novo Nordisk’s popular diabetes drug, Ozempic (semaglutide), have an increased risk of developing the rare eye condition, non-arteritic...

The investigation will include assessing findings from a 16,827-patient, US registry-based study that first signaled the risk last July, and two larger Danish studies that last month found that Ozempic...

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