Research Finds Novo Nordisk's (NVO.US) Weight Loss Drug May Cause "Blindness" Danish Regulator Seeks Investigation
1min read Zhitong Finance learned that the Danish Medicines Agency said it would ask European authorities to review two new studies that found a link between Novo Nordisk's (NVO.US) popular drug Ozempic and a rare form of vision loss. The Danish national regulator said on Monday it would ask the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) to assess Danish registration studies.
The studies, conducted by researchers at the University of Southern Denmark, "strengthened the suspicion of a link between Ozempic and a rare eye disease (called NAION)," the agency said.
Both independent studies found that people taking Ozempic were more than two times more likely to develop the eye disease, which can lead to blindness. Both studies appeared to confirm a link first suggested earlier this year by a study at Harvard University.
One of the studies was published last week on the medRxiv website, which posts research before it is reviewed by outside scientists. A Danish/Norwegian research team used data from thousands of patients who took Ozempic over many years. The second study looked at data from about 424,000 Danish diabetes patients, a quarter of whom took Ozempic.
Professor Jakob Grauslund, who led the study of 424,000 patients, said in a statement: "We used to see 60 to 70 cases of NAION per year. Now we see 150. We have noticed that more and more type 2 diabetes patients come to the hospital because of NAION."
Novo Nordisk said it had thoroughly reviewed the studies and conducted its own internal safety assessment, finding that the benefit-risk profile of Ozempic had not changed. NAION is not listed as a side effect of the drug on its label.
As of Dec. 10, the Danish regulator had received 19 reports of NAION in patients taking Ozempic and Wegovy, a spokesperson, Mia J rgensen, noted. The rare disease, which was first reported in Denmark in July, is suspected to be a side effect of the active ingredient semaglutide in the two drugs.
NAION occurs when blood flow to the optic nerve is disrupted, most commonly in people over 50. While rare, the eye disease is irreversible and untreatable and can lead to blindness, doctors say, and patients should be informed of the potential risks.