Full Breakdown
Lawsuits Over GLP-1 Drugs Claim Inadequate Warning for Rare Eye Disorder
By Drooid · · How we work
Core Event
Todd Engel, a former heavy-machinery operator from Maryland, sued Novo Nordisk, maker of Ozempic (semaglutide), alleging the company failed to warn about non-arteritic anterior ischemic optic neuropathy (NAION). Engel lost vision in his right eye in early 2023 and, after continuing the medication, lost his left eye seven months later. His case is part of two consolidated multi-district litigations that together include 247 plaintiffs with NAION and more than 4,000 with serious digestive complications.
Background & Context
GLP-1 receptor agonists, approved for type-2 diabetes, are now widely prescribed for weight loss and other metabolic conditions. A recent Gallup analysis found more than one in ten Americans are currently taking a GLP-1 drug, and one in seven have taken one at some point.
Data & Statistics
- FDA adverse-event reports filed voluntarily since 2024 list over 1,000 reports of optic neuropathy linked to GLP-1 drugs, out of roughly 190,000 total reports for these medications.
- The same database contains 1,928 reports of pancreatitis, including 135 cases of necrotizing pancreatitis.
- Clinical-trial data, according to Novo Nordisk, show NAION and other serious conditions are “exceedingly rare,” though exact incidence rates were not disclosed.
- A JAMA Ophthalmology observational study identified a higher rate of NAION among diabetic patients taking semaglutide, but the authors and the American Academy of Ophthalmology (AAO) and the North American Neuro-Ophthalmology Society (NANOS) emphasized that correlation does not prove causation.
Official Statements & Responses
- Novo Nordisk: Maintains that NAION and similar events are exceedingly rare in trials and that the lawsuits lack merit. It continues to share adverse-event data with the FDA, which has not requested label changes.
- Eli Lilly (maker of Mounjaro and Zepbound): Stated it will “vigorously defend against these claims.”
- American Academy of Ophthalmology and North American Neuro-Ophthalmology Society: Issued a consumer clarification noting that the JAMA study cannot establish causation, acknowledged a potential link, and advised patients not to discontinue GLP-1 therapy without medical guidance.
On-the-Ground Report
Engel’s experience illustrates the personal impact of the alleged warning gap. Unaware of emerging research, he continued weekly injections until his left eye also went blind. He now describes the loss of sight as preventing him from working, walking on the beach, and seeing his wife’s face.
Conflicting Reports & Gaps
- Scientific evidence: The JAMA study shows an association between semaglutide use and higher NAION rates, but the AAO and NANOS stress that the study cannot prove causation.
- Regulatory stance: Novo Nordisk and the FDA assert that existing data do not warrant label changes, while plaintiffs contend that the voluntary reporting system is insufficient for detecting rare harms.
- Reporting reliability: FDA adverse-event submissions are voluntary and unverified, raising questions about the completeness and accuracy of the data used to assess risk.
What’s Next
The FDA has indicated it will complete its NAION risk assessment and decide whether a warning-label update is needed. No specific timeline has been provided, and the drugs remain widely prescribed while litigation proceeds.