Australia adds rare vision disorder warning to all GLP-1 labels, including Ozempic and Mounjaro

Australia's Therapeutic Goods Administration has added a rare eye disorder to the product information for every GLP-1 receptor agonist sold in the country, including semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro), liraglutide (Saxenda) and dulaglutide (Trulicity) ^[1][2].

The class-wide safety update, published July 23, 2026, describes non-arteritic anterior ischemic optic neuropathy (NAION) as rare but serious, with the potential for permanent visual impairment up to blindness, and states that no treatment has been shown to improve visual acuity outcomes ^[1]. Australian health professionals are being asked to advise patients to seek urgent ophthalmological examination for sudden vision loss, including partial loss ^[1][2].

The regulator's adverse event database lists 36 cases of optic ischemic neuropathy tied to these medicines: 23 involving semaglutide, 10 involving tirzepatide and three involving liraglutide ^[1][2]. No cases were recorded for dulaglutide, although one semaglutide report involved a patient with prior dulaglutide use ^[1][2].

The review goes back to July 2024, when a study in JAMA Ophthalmology prompted the TGA to watch for a possible link ^[1]. An independent assessment produced what the agency called conflicting evidence, so the question went to the Advisory Committee on Medicines in October 2025 ^[1]. That committee found the evidence might support a signal for semaglutide but not for dulaglutide or tirzepatide ^[1]. The agency said its updates "should not imply a causal association, but reflect a class level awareness" ^[1].

Semaglutide's product information picked up the most new language. It now notes that people with an anatomical predisposition known as "disc at risk" are at the highest risk of NAION whether or not they take a GLP-1, that an optometrist or ophthalmologist can assess that pre-existing risk, and that some epidemiological studies indicate an increased risk of NAION during semaglutide treatment ^[1]. The agency said no time interval for the condition's development has been identified ^[1].

Dr Terri-Lynne South, chair of RACGP Specific Interests Obesity, estimated the added risk at between two and 18 cases of NAION per 100,000 GLP-1 users per year ^[1]. She said the condition's risk factors — type 2 diabetes, high blood pressure, obstructive sleep apnea, increasing age and a low cup-to-disc ratio — overlap with why many people take these drugs, and that patients with type 2 diabetes should already be getting annual back-of-the-eye checks ^[1].

Professor Helen Danesh-Meyer of the Royal Australian and New Zealand College of Ophthalmologists called NAION "a very rare condition" that needs to be kept in perspective. She pointed to heart attacks, stroke and kidney disease as common conditions these drugs treat, and said doctors do not need to withhold the medication from a patient unless that patient has underlying eye conditions ^[2].

Novo Nordisk, which makes Ozempic, Wegovy and Saxenda, said it continuously monitors the safety of its medicines with regulators including the TGA ^[2]. The company cited more than 49 million patient years of post-marketing exposure to semaglutide and said it believes the drug's benefit-risk profile remains favorable ^[2]. The European Medicines Agency and the World Health Organization issued alerts last year about semaglutide and a possible increased risk of NAION ^[1].

The TGA does not recommend that patients stop treatment without first consulting a doctor, and it placed no new restrictions on prescribing ^[2].

Why it matters for patients

The labeling change applies in Australia, and the 36 reports came through that country's system ^[1][2]. No matching change to US prescribing information has been reported.

The symptoms are the actionable part of the warning. The TGA advises urgent ophthalmological attention for sudden vision loss, including partial loss ^[1][2]. Dr South noted that people with type 2 diabetes should be having yearly back-of-the-eye checks, which can also show whether a person has the anatomical feature the updated semaglutide information flags ^[1].

The absolute numbers stay small. Dr South's estimate of two to 18 extra cases per 100,000 users per year comes alongside her point that diabetes, high blood pressure and sleep apnea are themselves risk factors for this eye condition, which makes it hard to pin any single case on a drug ^[1]. Professor Danesh-Meyer said the benefits of the drug class for diabetes and obesity remain significant, and both experts framed the eye risk as uncommon next to the conditions the medicines are prescribed to manage ^[1][2].

What happens next

Updated product information and consumer medicine information are in effect in Australia now ^[1]. The TGA began monitoring the question in July 2024 and took it to its medicines advisory committee in October 2025 ^[1]. The European Medicines Agency and the World Health Organization issued their semaglutide alerts in the past year ^[1]. Whether the US Food and Drug Administration will take similar action has not been disclosed.