Overview
- The FDA told makers on Monday to add warnings about non‑arteritic anterior ischemic optic neuropathy, a rare condition that can cause sudden, painless vision loss and sometimes permanent damage.
- The agency’s analysis pooled 126 randomized trials with about 134,000 participants and identified 15 probable NAION cases, 10 in GLP‑1 recipients and five in controls, equal to about 6.4 versus 3.8 cases per 100,000 patient‑years.
- Regulators said causation was not established and animal data gave no clear mechanism, so clinicians should urgently evaluate any sudden visual changes and consider ophthalmology referral before changing therapy.
- Manufacturers including Novo Nordisk and Eli Lilly disputed a proven causal link and said they are reviewing the update while hundreds of plaintiffs continue lawsuits alleging vision loss.
- The FDA action follows a 2025 EMA label change for semaglutide and leaves open effects on prescribing, patient counseling, and further research to sort drug risk from common comorbidities that raise NAION risk.