Novo Nordisk, the manufacturer of the diabetes medication Ozempic, faces scrutiny following findings from two large studies conducted by the University of Southern Denmark. These studies suggest that patients undergoing treatment with Ozempic are at a doubled risk of developing non-arteritic anterior ischemic optic neuropathy (NAION), a rare but serious disease affecting the optic nerve. Despite this increased relative risk, the absolute risk remains low, with only 2 out of every 10,000 patients affected.
Researchers utilized comprehensive data from Danish and Norwegian health registers to conduct the studies, which validated earlier concerns from a smaller American study. The findings have prompted calls for healthcare professionals to discuss the potential risks and benefits of Ozempic with their patients.
“The core finding I guess is the simple fact that we see more cases of NAION, a very rare but serious disease of the optic nerve, among users of semaglutide than among users of other antidiabetic medications. This finding is very consistent across all the analyses we’ve tried coming up with. While we don’t know why this happens, it seems the drug increases the risk of this disease.” — Professor Anton Pottegård
Novo Nordisk emphasizes its commitment to patient safety and takes all reports of adverse events seriously. The company notes that NAION is not listed as an adverse drug reaction for Ozempic in its approved labels. Nonetheless, they acknowledge the importance of these findings in guiding discussions between doctors and 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
While the studies indicate a significant increase in NAION cases among diabetic patients treated with Ozempic, they do not establish a causal relationship between semaglutide, the active ingredient in Ozempic, and NAION. Experts stress the need for further scientific testing to confirm any hypothesis linking semaglutide to this condition.
“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 absolute risk of NAION remains very low, with only 1 out of every 10,000 patients developing the condition annually. However, for those taking Ozempic, this risk doubles to 2 per 10,000 patients. This doubling of relative risk highlights the importance of careful consideration when prescribing this medication.
“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
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