Denmark Requests EU Review Over Concerns That Ozempic May Cause Vision Loss

The Danish Medicines Agency has announced its intention to request a review from the European Pharmacovigilance Risk Assessment Committee (PRAC) regarding potential links between Novo Nordisk A/S's diabetes drug Ozempic and a rare type of vision loss known as non-arteritic anterior ischemic optic neuropathy (NAION). This move follows findings from two new studies conducted by the University of Southern Denmark that indicate an increased risk of this eye condition in patients using Ozempic.

The agency disclosed this development on Monday, highlighting that the studies independently showed that individuals treated with Ozempic are more than twice as likely to develop NAION. NAION is a serious eye disorder that can lead to blindness. These findings are consistent with earlier suspicions raised by a previous study from Harvard University earlier this year.

One of the studies published last week on medRxiv was conducted by a Danish-Norwegian research team analyzing comprehensive data from tens of thousands of patients prescribed Ozempic. The other study examined records of approximately 424,000 Danish diabetes patients, of which a quarter had been treated with the medication.

The Danish Medicines Agency's request for a PRAC assessment is a precautionary measure aimed at further investigating potential health risks associated with Ozempic. This step underscores the importance of drug safety and the necessity for ongoing monitoring of pharmaceutical products post-approval.