Patient safety remains a top priority for Novo Nordisk, as recent studies from the University of Southern Denmark highlight a potential link between the antidiabetic medication Ozempic and an increased risk of a rare eye condition. Conducted using comprehensive data from Danish and Norwegian health registers, these studies suggest a significant rise in cases of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) among diabetic patients treated with semaglutide, the active ingredient in Ozempic. While the absolute risk remains low, the findings encourage further discussions between healthcare providers and patients regarding treatment options.
The two large-scale studies validate earlier concerns raised in a smaller American study, indicating more instances of NAION among semaglutide users compared to those taking other antidiabetic medications. NAION, although rare, is a serious disease affecting the optic nerve. The core finding is that two out of every 10,000 patients treated with semaglutide developed NAION annually, compared to one patient per 10,000 in the comparator group.
“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
Despite the observed association, researchers did not establish a causal link between semaglutide and NAION. Novo Nordisk emphasizes that NAION is not listed as an adverse drug reaction for marketed formulations like Ozempic, Rybelsus, and Wegovy.
“NAION is a very rare eye disease, and it is not an adverse drug reaction for the marketed formulations of semaglutide (Ozempic, Rybelsus and Wegovy) as per the approved labels.” — Novo Nordisk
Novo Nordisk remains committed to patient safety and takes all reports of adverse events seriously. The company underscores that decisions regarding prescription medicines should be made in consultation with healthcare professionals who can evaluate the benefits and potential risks for individual 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 call for further research to explore the prevalence of NAION and its possible connection to semaglutide. Dr. Howard Krauss advises that retrospective reviews like these should be published with cautionary notes to avoid public misperception and prompt scientific exploration into whether semaglutide may trigger 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 studies serve as a critical alert for ongoing monitoring of Ozempic's effects on diabetic patients. Healthcare professionals are encouraged to discuss these findings with patients, considering both the benefits and risks when prescribing this medication.
Leave a Reply