EU Regulator to Investigate Potential Link Between Ozempic and Rare Eye Condition NAION

Investigation Initiated:
The European Medicines Agency (EMA) has announced it will review a potential link between Novo Nordisk's diabetes drug Ozempic and a rare eye condition known as nonarteritic anterior ischemic optic neuropathy (NAION)15.

Studies Indicate Risk:
Two studies from the University of Southern Denmark suggest that patients taking Ozempic may have an increased risk of developing NAION, a condition that can lead to sudden vision loss and visual field defects24.

Regulatory Action:
The Danish Medicines Agency has requested the European Pharmacovigilance Risk Assessment Committee (PRAC) to assess these new studies to determine if there is a link between semaglutide, the active ingredient in Ozempic, and NAION2.

Novo Nordisk's Response:
Novo Nordisk emphasizes that the studies did not establish a causal relationship between semaglutide and NAION, and the company's internal safety assessment concludes that the benefit-risk profile of semaglutide remains unchanged1.

Rare Condition:
NAION is an extremely rare condition, and it has not been established whether Ozempic is the cause of the reported increase in NAION cases or if other factors are involved24.

Previous Reports:
The Danish Medicines Agency has received 19 reports of NAION associated with semaglutide use since July 2024, but previous data was not strong enough to prove a link24.

Ongoing Review:
The EMA's safety committee is currently assessing whether patients treated with semaglutide have an increased risk of developing NAION15.

Sources:

1. https://www.investing.com/news/stock-market-news/eu-regulator-to-review-potential-link-between-ozempic-and-eye-condition-93CH-3779454

2. https://laegemiddelstyrelsen.dk/en/news/2024/suspicion-of-rare-eye-condition-from-ozempic-use-to-be-investigated-further/

4. https://qtxasset.com/cdn-cgi/image/w=384,h=216,f=auto,fit=crop,g=0.5x0.5/https:/qtxasset.com/quartz/qcloud5/media/image/GettyImages-1312083976.jpg?VersionId=RbJboHK8p2cGpt3Bka8k3.Vrb.RxQnv&sa=X&ved=2ahUKEwjqraa03LKKAxV8LFkFHT4vLgMQB16BAgDEAI

5. https://www.morningstar.com/news/dow-jones/202412184133/eu-drug-regulator-to-review-ozempics-possible-link-to-eye-condition-update