Two extensive studies conducted by the University of Southern Denmark have revealed a potentially increased risk of an eye disorder known as Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) among users of the diabetes medication Ozempic, the brand name for semaglutide. The research, drawing on data from Danish and Norwegian health registers, suggests that patients using semaglutide may experience double the risk of developing NAION compared to those using other antidiabetic medications. Despite these findings, Novo Nordisk, the pharmaceutical company behind Ozempic, emphasizes that patient safety remains their top priority and that the absolute risk of this condition is very low.
The studies' findings indicate that out of 10,000 patients treated with semaglutide in a year, approximately two individuals developed NAION, compared to one case in the comparator group. Researchers suggest that while the relative risk appears to double, the absolute risk remains minimal. Nonetheless, the core finding highlights more cases of this rare optic nerve disease among semaglutide users than among those using other treatments.
“While both studies showed a roughly doubling of relative risk, the absolute risk and absolute number of people affected is very low. This aligns with the very low annual incidence of this rare disorder. One of the studies found that 2 people per 10,000 patients treated with semaglutide in a year developed NAION versus 1 out of every 10,000 in the comparator group, concluding that the absolute risk is very low. The studies did not demonstrate a causal relationship between semaglutide and NAION.” — Novo Nordisk
The findings support earlier concerns raised in a smaller American study and call for further scientific investigation into whether semaglutide could trigger NAION. However, Novo Nordisk points out that there is currently no established causal relationship between their medication and NAION.
“A retrospective review of this nature should be published with editorial caveats to minimize public misperception. A report of this nature should lead to scientific testing of a hypothesis which may be proposed, that semaglutide may trigger NAION, but at this time it is nothing more than a hypothesis.” — Howard Krauss, MD
The researchers advocate for discussions between patients and doctors regarding the benefits and risks associated with semaglutide treatment, particularly considering eye conditions are known comorbidities for diabetes patients.
“Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from use of our medicines very seriously. This also relates to eye conditions, which are well-known comorbidities for people living with diabetes. Any decision to start treatment with prescription-only medicines should be made in consultation with a healthcare professional who should do a benefit-risk evaluation for the patient in question, weighing up the benefits of treatment with the potential risks.” — Novo Nordisk
Experts emphasize that while the condition is rare, understanding its prevalence and possibly identifying those at risk is crucial for advancing patient safety and care.
“Also, this should lead to research into the actual prevalence of the problem (which might be underrecorded using the highly specific diagnostic requirements used in our studies), research into the underlying mechanism (currently unknown) and research into the identification of patients at risk of this adverse effect,” — Howard Krauss, MD
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