The European Medicines Company (EMA) has concluded that semaglutide-based medicines – together with Ozempic, Wegovy, and Rybelsus – enhance the danger of a critical eye situation that may result in sudden imaginative and prescient loss.
Following a complete security evaluate, the EMA’s Pharmacovigilance Threat Evaluation Committee (PRAC) decided on Friday that non-arteritic anterior ischemic optic neuropathy (NAION) must be listed as a “very uncommon” facet impact of semaglutide – the primary element of weight-loss and anti-diabetic medication produced by Novo Nordisk.
The EU well being watchdog’s evaluate, initiated in January 2025, analyzed information from medical trials, post-marketing surveillance, and medical literature. Findings recommend that adults with sort 2 diabetes taking semaglutide have roughly twice the danger of creating NAION in comparison with these not on the treatment. The “very uncommon” facet impact classification signifies that the situation might have an effect on as much as 1 in 10,000 customers.
NAION is the second commonest reason behind optic nerve-related blindness after glaucoma. Sufferers experiencing sudden imaginative and prescient loss or quickly worsening eyesight whereas on semaglutide are suggested to hunt fast medical consideration and discontinue use if NAION is identified.
The Denmark-based firm Novo Nordisk owns the patent on semaglutide, a GLP-1 receptor agonist used for managing sort 2 diabetes and weight problems. It features by enhancing insulin secretion and selling a sense of fullness, thereby aiding in blood sugar management and weight administration.
A current research additionally indicated that Ozempic and related medicines might enhance the danger of kidney most cancers. Nevertheless, the medication reportedly decrease the danger of greater than a dozen different cancers, suggesting their general profit should still outweigh the hazards. Moreover, the EMA beforehand investigated studies of suicidal ideas related to semaglutide use, although no definitive causal relationship was established.
The EMA’s suggestions will now be reviewed by the Committee for Medicinal Merchandise for Human Use (CHMP) earlier than a ultimate determination is adopted by the European Fee. Novo Nordisk, which was dethroned as Europe’s most precious firm earlier this 12 months, has said its dedication to affected person security and is working with the EMA to replace product labels accordingly.
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