US Ozempic label still lacks NAION warning as other regulators act

As of the May 2026 revision of Ozempic's US prescribing information, the label still does not include a warning about non-arteritic anterior ischemic optic neuropathy (NAION), an eye condition that can cause loss of vision ^[1]. Regulators in Europe, the United Kingdom and Australia have concluded that NAION is a rare side effect of semaglutide — the active ingredient in Ozempic, Wegovy and Rybelsus — and have moved to add it to product information ^[1][2].

What other regulators concluded

The European Medicines Agency's safety committee, PRAC, finished its review on June 6, 2025, and revised the announcement on June 13, 2025 ^[2]. It concluded that NAION is a "very rare" side effect of semaglutide, a category meaning it may affect up to 1 in 10,000 people taking the medicine ^[2]. The committee reviewed non-clinical studies, clinical trials, post-marketing surveillance and the medical literature ^[2].

Several large epidemiological studies found that adults with type 2 diabetes taking semaglutide had roughly a two-fold higher risk of developing NAION than people not taking it, which works out to about one additional case per 10,000 person-years of treatment ^[2]. Data from clinical trials also pointed to a slightly higher risk than placebo ^[2]. The EMA recommended updating product information for semaglutide medicines, and said patients who experience sudden loss of vision or rapidly worsening eyesight during treatment should contact a doctor without delay; if NAION is confirmed, treatment with semaglutide should be stopped ^[2].

Other agencies have acted as well. The UK's MHRA published a drug safety update on semaglutide and NAION risk, and the World Health Organization issued a notice on June 27, 2025 ^[1]. On July 23, 2026, Australia's Therapeutic Goods Administration issued a Medicines Safety Update titled "GLP-1 RAs and rare vision disorder," stating that NAION warnings would be added in Australia ^[1]. That Australian update frames the issue around GLP-1 receptor agonists as a class, while the EMA's conclusion covered semaglutide specifically ^[1][2].

The US label and the lawsuits

The current Ozempic prescribing information in the United States, revised 5/2026, still does not include warnings about NAION or other eye side effects ^[1]. Vision-loss lawsuits are being filed in the US against Novo Nordisk over the absence of those warnings ^[1]. A plaintiffs' law firm that publishes case updates says that because the label contains no NAION warning, the lawsuits are not being filed against the doctors who prescribed Ozempic to people who later suffered vision loss ^[1].

Why it matters for patients

Where a patient lives currently determines whether NAION appears in the official prescribing information for their semaglutide medicine. In the European Union, the UK and soon Australia, the risk is described as very rare, with the estimate of up to 1 in 10,000 users and roughly one extra case per 10,000 person-years of treatment ^[1][2]. In the US, a person reading the Ozempic label as of May 2026 would find no mention of it ^[1].

NAION can cause vision loss, and the EMA's guidance to patients is to seek medical attention without delay for sudden vision loss or rapidly worsening eyesight during treatment ^[2]. The two sources do not report how many NAION cases have been documented in the US, and the FDA has not announced whether it will add a warning ^[1][2]. The EMA's conclusion applies to semaglutide products; whether the same conclusion extends to other GLP-1 medicines has not been established by these documents ^[1][2].

What happens next

Australia's TGA has said NAION warnings will be added there, following its July 23, 2026 safety update ^[1]. In the US, no change to the Ozempic label has been disclosed as of late July 2026, and the vision-loss litigation against Novo Nordisk remains active ^[1].