其中一篇文章上周出现在了medRxiv网站上，该网站在外部科学家对研究进行审查之前就会发布研究结果。一个丹麦/挪威的研究小组使用了数万名服用Ozempic的患者多年来的数据。第二项研究调查了约42.4万名丹麦糖尿病患者的数据，其中四分之一的人接受了Ozempic。The Danish Medicines Agency stated that it would require European authorities to review two new studies suggesting a link between Novo-Nordisk A/S's best-selling drug Ozempic and a rare form of vision loss.
According to Zhitong Finance, the Danish Medicines Agency stated that it would require European authorities to review two new studies indicating that Novo-Nordisk A/S's (NVO.US) best-selling drug Ozempic is linked to a rare form of vision loss. The Danish national regulatory agency announced on Monday that it would request the European Pharmacovigilance Risk Assessment Committee (PRAC) to evaluate the registered studies in Denmark. The agency noted that two large studies from the University of Southern Denmark "reinforced the suspicion of a connection between Ozempic and a rare eye disease known as NAION."
Both independently conducted studies found that individuals taking Ozempic had more than double the risk of developing this eye disease, which can lead to blindness. Both appeared to confirm the link initially raised by a Harvard University study earlier this year.
One of the articles was published last week on the medRxiv website, which releases research results prior to external peer review. A Danish/Norwegian research group used data from thousands of Ozempic users over the years. The second study analyzed data from approximately 0.424 million Danish diabetes patients, of whom a quarter were taking Ozempic.
Jakob Grauslund, an ophthalmology professor who led the study involving 0.424 million participants, stated in a statement, "In the past, we saw 60 to 70 cases of NAION each year; now we are seeing 150 cases. We have noticed an increase in 2 type diabetes patients coming to the hospital due to NAION."
Novo-Nordisk A/S stated that it has thoroughly reviewed both studies and conducted its own internal safety assessment, finding no change in the benefit/risk profile of Ozempic. Currently, NAION is not listed as a side effect of the drug on its label.
Spokesperson Mia Jørgensen noted that as of December 10, the Danish regulator has received 19 reports of NAION occurring among patients taking Ozempic and Wegovy. In July of this year, Denmark first reported this rare disease, suspecting it was a side effect of the active ingredient semaglutide in the above two drugs.
NAION occurs when insufficient blood flow damages the optic nerve and is most common in individuals over the age of 50. Although rare, this eye disease is irreversible and untreatable, potentially leading to blindness, and doctors say patients should be informed of the possible risks.
