Patient safety remains a top priority for Novo Nordisk as recent studies from the University of Southern Denmark uncover an increased incidence of NAION, a rare disease affecting the optic nerve, among users of semaglutide, a key component of Ozempic. Researchers conducted comprehensive analyses using data from Danish and Norwegian health registers, finding that the risk of developing NAION is doubled for those on semaglutide compared to other antidiabetic medications. Despite the heightened risk, experts emphasize that the absolute risk remains low.
The studies revealed that out of every 10,000 patients treated with semaglutide annually, two developed NAION. In contrast, only one in 10,000 patients in the comparator group experienced this condition. NAION, although serious, is notably rare, and these findings validate earlier concerns raised by a smaller American study. Novo Nordisk has reiterated its commitment to patient safety, noting that they take all reports of adverse events seriously.
"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." — Novo Nordisk
While the studies indicate a significant increase in NAION cases among users of Ozempic, they do not establish a direct causal relationship between the drug and the disease. The hypothesis that semaglutide may trigger NAION necessitates further scientific investigation.
"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 suggest that these findings should prompt discussions between doctors and patients regarding the benefits and risks associated with Ozempic. They advise healthcare professionals to conduct thorough benefit-risk evaluations before prescribing the medication.
"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
The core discovery highlights more instances of NAION among semaglutide users compared to other antidiabetic medications. This finding remains consistent across various analyses conducted by researchers.
“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.” — Professor Anton Pottegård
Novo Nordisk maintains that NAION is not listed as an adverse reaction for semaglutide's marketed formulations such as Ozempic, Rybelsus, and Wegovy per their approved labels.
“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
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