Ozempic, Wegovy linked to rare vision-loss disorder, EU regulator warns
Following a months-long safety review, the EMA's Pharmacovigilance Risk Assessment Committee concluded that semaglutide, the active ingredient in Ozempic, Wegovy, and Rybelsus, is associated with rare occurrences of non-arteritic anterior ischemic optic neuropathy (NAION), a condition caused by reduced blood flow to the optic nerve.
The disorder is the second-most common cause of blindness due to optic nerve damage, after glaucoma. The EMA said NAION could affect up to 1 in 10,000 patients taking semaglutide and that the risk of developing the condition is roughly double that of individuals not using the medication.
The EMA began investigating the link between semaglutide and NAION in December 2023 after earlier studies signaled a possible connection. One large observational study involving nearly 350,000 type 2 diabetes patients showed that long-term semaglutide use more than doubled the risk of developing NAION compared to those on alternative treatments.
This marks the first time a regulatory body has formally acknowledged the connection, though academic research had previously pointed to the risk.
Semaglutide is part of a class of drugs known as GLP-1 receptor agonists, which regulate blood sugar and promote a feeling of fullness, making them widely prescribed for both diabetes management and weight loss.
The EMA has recommended that Novo Nordisk update prescribing information for all semaglutide-containing products to include NAION as a potential side effect, categorized as 'very rare.'
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The European Medicines Agency (EMA) said on Friday that Novo Nordisk's popular drugs Ozempic and Wegovy may, in very rare cases, cause a serious eye disorder that can lead to vision loss. Following a months-long safety review, the EMA's Pharmacovigilance Risk Assessment Committee concluded that semaglutide, the active ingredient in Ozempic, Wegovy, and Rybelsus, is associated with rare occurrences of non-arteritic anterior ischemic optic neuropathy (NAION), a condition caused by reduced blood flow to the optic nerve. The disorder is the second-most common cause of blindness due to optic nerve damage, after glaucoma. The EMA said NAION could affect up to 1 in 10,000 patients taking semaglutide and that the risk of developing the condition is roughly double that of individuals not using the medication. The EMA began investigating the link between semaglutide and NAION in December 2023 after earlier studies signaled a possible connection. One large observational study involving nearly 350,000 type 2 diabetes patients showed that long-term semaglutide use more than doubled the risk of developing NAION compared to those on alternative treatments. This marks the first time a regulatory body has formally acknowledged the connection, though academic research had previously pointed to the risk. Semaglutide is part of a class of drugs known as GLP-1 receptor agonists, which regulate blood sugar and promote a feeling of fullness, making them widely prescribed for both diabetes management and weight loss. The EMA has recommended that Novo Nordisk update prescribing information for all semaglutide-containing products to include NAION as a potential side effect, categorized as 'very rare.'
