Science

FDA Orders NAION Blindness Risk Warning on All GLP-1 Drugs Including Ozempic and Wegovy

The FDA is requiring all GLP-1 drugs, including Ozempic and Wegovy, to warn about NAION, a rare eye condition that can cause permanent blindness.

The update

The US Food and Drug Administration is requiring all GLP-1 medicines, including Ozempic, Wegovy, Mounjaro, Zepbound and Soliqua, to warn about nonarteritic anterior ischemic optic neuropathy (NAION), a sudden reduction in blood flow to the optic nerve that can cause painless, permanent vision loss in one eye. Reviewing 126 trials involving over 134,200 patients, the FDA found an incidence of 6.4 cases per 100,000 person-years among GLP-1 patients, compared with 3.8 among patients on placebo or other glucose-lowering medicines, and identified 15 probable cases overall.

Why it matters

GLP-1 drugs are used worldwide for type 2 diabetes and obesity, so even a rare risk reaches a large population. No treatment can reverse vision loss from NAION. Novo Nordisk said the data do not establish a cause-and-effect relationship and that it remains confident in the benefit-risk profile of its medicines. The American Academy of Ophthalmology said any added risk appears small.

What to watch

Watch whether regulators outside the United States follow with label changes, after Europe earlier estimated that up to 1 in 10,000 semaglutide users could be affected. Ophthalmologists advise patients who notice sudden, painless vision loss in one eye to seek care promptly, and not to stop their medication without talking to their doctor.

Sources

  • theguardian.com — FDA decision, trial review and incidence figures
  • bbc.co.uk — FDA order, NAION explanation and ophthalmology advice

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