GLP-1 Lawsuits Challenge Drugmakers Over Serious Health Risks

Thousands of patients are pursuing legal claims alleging serious harm from GLP-1 medications, including vision loss and digestive complications. One plaintiff, Maryland resident Todd Engel, says he became blind in both eyes after beginning Ozempic for diabetes in early 2023. His lawsuit alleges that manufacturer Novo Nordisk failed to adequately warn patients and doctors about the potential risks.

Engel, who operated heavy machinery around warehouses and highways for four decades, experienced sudden vision loss in his right eye on New Year's Eve. His doctor diagnosed nonarteritic anterior ischemic optic neuropathy, known as NAION, a condition associated with reduced blood flow to the optic nerve. His left eye subsequently suffered similar damage.

Engel said the sudden loss of sight left him unable to work or walk along the beach without assistance.

"I couldn't see anything. It was all dark. It was black." Engel described his initial experience of vision loss.

His wife, Shelley Engel, recalled asking their doctor whether Ozempic could have contributed to the condition. The physician's response, according to Shelley, reflected the limited awareness of a possible connection at the time.

"We have heard nothing about that," Shelley recalled the doctor telling her.

Seven months later, research published in JAMA Ophthalmology found an association between NAION and the use of Ozempic, whose active ingredient is semaglutide, among patients with diabetes. Engel and his doctor had not been aware of the research when he continued his weekly injections.

More than one in 10 Americans are taking GLP-1 medications for weight loss, while one in seven has used them at some point, according to a recent Gallup analysis cited by NPR. The drugs are also prescribed for other conditions and can cause a range of side effects.

Two medical organizations, the American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society, cautioned that the observational research did not establish that the medications caused NAION. They acknowledged a potential association but said further research was needed. The groups did not recommend that patients stop taking GLP-1 medications.

"This is not the type of study that can show the treatment caused NAION," the organizations said in a consumer clarification.

The U.S. Food and Drug Administration maintains a database of adverse-event reports submitted by patients, doctors and drug manufacturers. Reporting is largely voluntary, and the agency does not verify individual reports, meaning the records can identify potential safety signals but cannot establish that a medication caused a reported condition.

NPR's analysis identified more than 1,000 reports of optic neuropathy associated with GLP-1 drugs since 2024, among nearly 190,000 adverse-event reports involving the medications during that period. The database also contained 1,928 reports of pancreatitis, including 135 cases identified as necrotizing pancreatitis.

The FDA told NPR that it was conducting its own study of NAION risks and assessing the claims. The agency said it would determine whether regulatory action was needed after completing its assessment.

Novo Nordisk, which manufactures Ozempic and Wegovy, pointed to subsequent research questioning whether its GLP-1 medication causes NAION. The company said the lawsuits lacked merit and maintained that NAION and other serious conditions were exceedingly rare in clinical trials. It also said it continued collecting and sharing post-market safety data with the FDA, which had not requested changes to warning labels.

Jonathan Orent, a court-appointed lead attorney in two major consolidated lawsuits involving alleged GLP-1-related injuries, argued that manufacturers should strengthen warnings for doctors and patients, including when complications are uncommon.

Orent said clinical trials have limitations when detecting rare adverse events and may not reflect the diversity of patients encountered in everyday medical practice.

"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 explained why he believes clinical trials may not identify uncommon complications.

Orent's cases include 247 plaintiffs alleging NAION and more than 4,000 plaintiffs reporting other serious digestive conditions, including pancreatitis and gallstones. He said clearer warnings could have affected patients' decisions about treatment.

"These warnings would have made a difference in the lives of real people," Orent said.

Eli Lilly, which manufactures Mounjaro and Zepbound containing the active ingredient tirzepatide, also faces claims related to alleged harm from GLP-1 medications. The company said it would contest the allegations.

"vigorously defend against these claims." Eli Lilly said in an emailed statement, describing its position on the lawsuits.

Engel said he would have stopped taking Ozempic if he had known about the potential risk of blindness. He has also described the personal consequences of losing his sight, including being unable to play ball with his grandchildren or see his wife's face.

"Being able to play ball … with my grandchildren, I can't do these things anymore," Engel said.

He also described the permanent loss of an everyday part of his relationship with his wife.

"I will never, never be able to see my wife's beautiful face every day." Engel said.

The central legal question is whether GLP-1 medications caused the injuries alleged by plaintiffs. Observational studies can identify associations, but determining causation requires additional evidence. The FDA's review of potential NAION risks remains ongoing, while the consolidated lawsuits continue to challenge drugmakers over their warnings and alleged failure to disclose serious complications.