Two consolidated lawsuits allege GLP-1 drugs blinded hundreds of patients

FDA database lists more than 1,000 optic neuropathy reports linked to GLP-1s since 2024

Todd Engel had operated heavy machinery — forklifts, rubber-tire loaders — around warehouses and highways in suburban Maryland for four decades. In early 2023, his doctor prescribed Ozempic for diabetes. On New Year’s Eve that winter, Engel woke up unable to see out of his right eye.

“I couldn’t see anything. It was all dark. It was black,” Engel told NPR, describing the sudden loss of vision. His doctor told him and his wife Shelley that he had developed NAION — non-arteritic anterior ischemic optic neuropathy — an inoperable condition caused by tiny strokes that cut off blood flow to the optic nerve.

Shelley Engel specifically asked whether Ozempic could be to blame. The doctor, she recalled, told them: “We have heard nothing about that.”

Seven months later, the journal JAMA Ophthalmology published research showing higher rates of NAION among diabetic patients taking semaglutide, the active ingredient in Ozempic. Neither Engel nor his doctor were aware of the study, so Engel kept taking his weekly injections. The following year, his left eye went dark too.

Engel is now a plaintiff in one of two consolidated multi-district lawsuits alleging that GLP-1 drugs — a class that includes Ozempic, Wegovy, Mounjaro, and Zepbound — caused life-threatening or life-altering harm. NPR reported the lawsuits include 247 plaintiffs with NAION and more than 4,000 plaintiffs with serious digestive conditions including pancreatitis and gallstones.

The FDA maintains a database tracking adverse events reported by doctors, patients, and drug companies. Reporting is mostly voluntary and the agency does not verify reports, but the database serves as a first step to prompt regulators to do further research and decide whether labels need updating.

NPR’s analysis of that database found more than 1,000 reports of optic neuropathy linked to GLP-1 drugs since 2024, out of nearly 190,000 total reports about the drugs over the same period, most of which were for minor gastrointestinal issues, dosing errors, or injection site redness. NPR also identified 1,928 reports of pancreatitis linked to GLP-1s in that span, including 135 cases of necrotizing pancreatitis, a potentially life-threatening form of the disease.

The central legal question in the lawsuits is whether the drugs caused the harm. Observational data — including the JAMA Ophthalmology study — can show correlation between GLP-1 use and adverse events but cannot establish causation, NPR reported. Two medical societies, the American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society, issued a consumer clarification saying: “This is not the type of study that can show the treatment caused NAION.” The groups acknowledged a potential link but said more research was needed and did not recommend that patients stop taking their medications.

Novo Nordisk, maker of Ozempic and Wegovy, said in a statement that NAION and other serious conditions are “exceedingly rare in clinical trials” and pointed to subsequent research casting doubt on whether the company’s GLP-1 drug causes NAION. The company said the cases are without merit and that it continues to share data with the FDA on side-effect reports; the agency has not requested warning-label changes, according to the company. Eli Lilly, whose Mounjaro and Zepbound contain the active ingredient tirzepatide, said it will “vigorously defend against these claims.”

The FDA told NPR it has undertaken its own study to assess NAION risks and will “determine the need for regulatory action” once its assessment is complete.

The plaintiffs’ lead attorney, Jonathan Orent, a court-appointed attorney on the multi-district litigation, argues that drugmakers should update warnings to doctors and patients — as they have in Europe — even if the conditions are rare, because clinical trials are too small to detect uncommon adverse events and do not capture the diversity of real-world populations. “You’re never going to have the population size to detect rarer events in a clinical trial; you’re also never going to have the diversity of your real world population,” Orent said. “These warnings would have made a difference in the lives of real people,” he added.

The scientific uncertainty cuts in multiple directions. Obesity and diabetes are complex metabolic diseases that affect many organs and increase risks for other ailments, which makes it hard to pinpoint whether problems patients encounter on GLP-1 drugs are caused by the drugs themselves. Emory University diabetes specialist Mohammed Ali said he did not report three patients who developed serious problems such as pancreatitis or gallstones while taking GLP-1s to the FDA’s adverse-events database because he could not be certain the drugs caused the conditions. “They may have had subclinical disease,” Ali said. “In other words, we didn’t know they had preexisting pancreatitis or preexisting gallstones.”

Online sales of GLP-1 drugs have also added to the difficulty of tracking side effects, according to pharmacist Robert Miller of the West Texas Poison Control Center. Miller said calls to poison-control centers about GLP-1 side effects — often vomiting — are rising, in part because patients buying through heavily marketed online channels often have little medical supervision. “So is there even a physician who’s motivated to report side effects or someone the patient feels they can report those side effects to?” Miller asked.

More than one in 10 Americans are taking a GLP-1 drug for weight loss, and one in seven has taken them at some point, according to a recent Gallup analysis cited by NPR.

Engel said he would have stopped taking Ozempic had he known the drug might put him at risk for blindness. He told NPR he mourns what he has lost — including the ability to work or to walk the beach unaided. “Being able to play ball … with my grandchildren, I can’t do these things anymore,” he said. “I will never, never be able to see my wife’s beautiful face every day.”

Shelley Engel said the lawsuit is also about warning labels. She said her husband’s “outgoing, vivacious personality has changed.” “This could have been prevented, if we only knew,” she said.

NPR correspondent Sydney Lupkin contributed to the report.