Ozempic's US label still carries no NAION warning

The US prescribing information for Ozempic (semaglutide), revised in May 2026, still does not include a warning about non-arteritic anterior ischemic optic neuropathy, or NAION, an eye condition that can cause sudden and often permanent vision loss ^[1]. Regulators in Europe, the United Kingdom and Australia have all moved to add NAION to semaglutide labeling, leaving US patients reading a different safety document than patients abroad ^[1][2].

What regulators outside the US have done

The European Medicines Agency's safety committee, the PRAC, concluded on 6 June 2025 that NAION is a "very rare" side effect of the semaglutide medicines Ozempic, Rybelsus and Wegovy, meaning it may affect up to 1 in 10,000 people taking the drug ^[2]. The committee reviewed non-clinical studies, clinical trials, post-marketing reports and the published literature before reaching that conclusion ^[2].

The numbers behind the decision are specific. Several large epidemiological studies suggest that semaglutide exposure in adults with type 2 diabetes is linked to roughly a two-fold increase in the risk of developing NAION compared with people not taking the medicine ^[2]. In absolute terms, the EMA said that works out to about one additional case per 10,000 person-years of treatment, where one person-year equals one person taking semaglutide for one year ^[2]. Clinical trial data also pointed to a slightly higher risk versus placebo ^[2].

The EMA recommended that product information for semaglutide medicines list NAION as a side effect with a frequency of "very rare," that patients who experience sudden loss of vision or rapidly worsening eyesight contact their doctor without delay, and that treatment be stopped if NAION is confirmed ^[2].

Other agencies followed or acted in parallel. The UK's MHRA issued a drug safety update covering NAION risk with Wegovy, Ozempic and Rybelsus ^[1]. The World Health Organization published a news item on semaglutide and NAION dated 27 June 2025 ^[1]. On 23 July 2026, Australia's Therapeutic Goods Administration published a Medicines Safety Update titled "GLP-1 RAs and rare vision disorder," stating that NAION warnings would be added in Australia and listing the earlier actions by the MHRA, EMA and WHO ^[1].

The US gap

Against that backdrop, the current US Ozempic label — the version marked "Revised: 5/2026" in FDA's Drugs@FDA database — still contains no warning about NAION or other Ozempic-related eye side effects, according to a review by a plaintiffs' drug injury law firm ^[1]. That firm is actively recruiting clients, so its framing is not neutral, but the label version it points to is a public FDA document ^[1].

US lawsuits over vision loss are being filed against Novo Nordisk on a failure-to-warn theory ^[1]. Because the current US label carries no NAION warning, those cases are being brought against the manufacturer rather than the prescribing physicians ^[1]. The sources provided here do not describe the size, schedule or current status of the consolidated federal litigation, and they do not say whether the FDA has completed its own review of NAION or when any US label change might occur. Those points are not yet known from this material.

Why it matters for patients

A drug label is the document that tells prescribers and pharmacists what risks to discuss. When a warning is absent, a US patient starting Ozempic may not hear about NAION during a visit, even though a patient in Germany, Britain or Australia would see it in the package information ^[1][2].

The absolute risk described by European regulators is small — about one extra case per 10,000 person-years — but NAION damage to the optic nerve can be permanent ^[2]. European regulators' guidance is that sudden vision loss or rapidly worsening eyesight during semaglutide treatment warrants prompt contact with a doctor, and that semaglutide be stopped if NAION is confirmed ^[2].

What happens next

Australia's TGA said in its 23 July 2026 update that NAION warnings would be added there ^[1]. Whether and when the FDA requires a similar change to the US Ozempic, Wegovy and Rybelsus labels is not addressed in these sources.