The evidence for a connection between the blockbuster weight loss drug and sight-stealing NAION is piling up.
The Ozempic (semaglutide injection; Novo Nordisk; Bagsværd, Denmark) elephant in the room, a rare blinding disease called non-arteric anterior ischemic optic neuropathy (NAION), is getting increasingly difficult to ignore.
On Monday, the Danish Medicines Agency (DMA) asked European officials to investigate after two new studies from the University of Southern Denmark (SDU) suggested a potential link between the blockbuster weight loss drug and the rare blinding disease.1
These findings match the conclusions of a retrospective study performed by Mass Eye and Ear earlier this year.
NAION is a rare condition where vision is lost due to damage in the anterior portion of the optic nerve. The damage is caused by an insufficient supply of blood to the nerve. In NAION, the cause is due to non-inflammatory disease in the blood cells (hence, the non-arteric, or ‘N’, in the disease name).
Growing evidence for Ozempic-NAION link
Over the past six months, the DMA has tracked cases of NAION in patients being treated with the drug. Up to December 10, 19 cases of the disease have been reported in Denmark.
In one of the SDU studies, investigators found that two people per 10,000 diabetic patients treated with Ozempic developed NAION, as opposed to one out of every 10,000 in the non-Ozempic diabetic group.
A 2012 study found normal incident rates between 2.3-10.2 per 100,000 people.2
“In the past six months, we have evaluated reports and studies involving the serious eye condition known as NAION in collaboration with our European colleagues,” said Dr. Line Michan, director of department at the Danish Medicines Agency.
“These new register-based studies provide comprehensive data from Danish and Norwegian registers that the European Pharmacovigilance Risk Assessment Committee may now consider. Therefore, we will now request PRAC to assess the new studies.”
More research needed for causality
Though the evidence for a link continues to grow, establishing a concrete causal relationship between semaglutides and NAION is still in early days. Dr. Michan has called for more research to isolate Ozempic as the cause of the disease.
NAION, though rare, is more common in diabetic patients2—a disease that Ozempic is frequently prescribed to treat. The lead investigator in the Mass Eye and Ear study, Dr. Joseph Rizzo, also called for more research in July.
“Our findings should be viewed as being significant but tentative, as future studies are needed to examine these questions in a much larger and more diverse population,” he said.
“This is information we did not have before, and it should be included in discussions between patients and their doctors, especially if patients have other known optic nerve problems like glaucoma—or if there is pre-existing significant visual loss from other causes.”
References
- Press Release. University of Southern Denmark. Available at: https://via.ritzau.dk/pressemeddelelse/14181495/dansk-diabetesmedicin-oger-risikoen-for-svaert-invaliderende-ojensygdom?publisherId=12056383&lang=da Accessed on 18 December 2024.
- Lee MS, Grossman D, Arnold AC, Sloan FA. Incidence of nonarteritic anterior ischemic optic neuropathy: increased risk among diabetic patients. Ophthalmology. 2011;118(5):959-963.
