Danish Medicines Agency Requests Review of Ozempic's Safety

The Danish Medicines Agency announced its intention to request a review by the European Committee for the Evaluation of Adverse Reactions (PRAC) concerning potential links between Novo Nordisk (NYSE: NVO) A/S's diabetes medication Ozempic and a rare form of vision loss known as non-arteritic anterior ischemic optic neuropathy (NAION). This action follows findings from two new studies conducted by the University of Southern Denmark, suggesting an increased risk of this eye condition in patients using Ozempic.

The agency disclosed this development on Monday, highlighting that the studies independently indicated that individuals treated with Ozempic had over a double risk of developing NAION, a serious eye disorder that can lead to blindness. These findings are consistent with suspicions raised by a prior study from Harvard University earlier this year.

One of the studies, which surfaced last week on medRxiv, was undertaken by a Danish-Norwegian research team that analyzed extensive patient data from tens of thousands of individuals prescribed Ozempic. The other study reviewed records from approximately 424,000 Danish patients with diabetes, with a quarter of them having been treated with the medication in question.

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

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