A European committee has assessed that the eye disease Naion is a rare side effect of the use of semaglutide.
The Danish pharmaceutical giant Novo Nordisk does not believe that there is a connection between the eye disease Naion and the use of semaglutide.
The company states this in a written response to DR.
“Based on all available data sources, Novo Nordisk has concluded that the data do not show a reasonable probability of a causal relationship between treatment with semaglutide and the development of Naion,” it says in the response to DR.
The European Adverse Reactions Committee Prac has otherwise assessed that the eye disease is a very rare side effect of semaglutide.
The Danish Medicines Agency wrote this in a press release earlier on Friday. It stated that the assessment was based on Prac having reviewed all available data on Naion in connection with semaglutide.
Both the diabetes drug Ozempic and the weight loss drug Wegovy are based on semaglutide. The older diabetes drug Rybelsus also contains semaglutide. All drugs are produced by Novo Nordisk.
Naion is a rare eye disease that affects the optic nerve of the eye, causing sudden loss of vision in one or, less commonly, both eyes.
The fact that it is a very rare side effect means that the side effect is expected to affect fewer than one in 10,000 patients.
According to Prac, the risk should be stated in the package leaflet in the side effects section.
If symptoms of the eye disease occur, treatment with semaglutide should be stopped, according to the Danish Medicines Agency.
Now the CHMP must respond to the assessment from Prac.
If the CHMP also recommends an update of the package leaflet, it must be submitted as a recommendation to the European Commission, which will make the final decision. This is what the Danish Medicines Agency writes.
Both Prac and CHMP are part of the European Medicines Agency, EMA.
The concern about the possible side effect of semaglutide was raised in two Danish studies from the University of Southern Denmark, among others.
The studies prompted the Danish Medicines Agency to ask Prac to look into the possible side effects.
According to the Danish Medicines Agency, diabetes, high blood pressure, high cholesterol and severe obesity are some of the known risk factors for Naion. Especially in combination with type 2 diabetes.
Therefore, it can be difficult to determine whether cases of Naion are due to the medication or health reasons.
The Danish Medicines Agency states that up to and including May 2025, it has received 28 reports about Naion from Danish patients who have been treated with semaglutide.
Of these, 15 patients received Wegovy, 13 received Ozempic. One of the patients received both Ozempic and Rybelsus.
The first reports of the eye disease from Danish patients treated with semaglutide came in the summer of 2024, it says.
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