Shelley and Todd Engel.
The Engel family
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The Engel family
Todd Engel had been driving heavy machinery, like forklifts and wheel loaders, around warehouses and highways in suburban Maryland for four decades.
In early 2023, Engel’s doctor started him on Ozempic, a GLP-1, for diabetes. That winter, on New Year’s Eve, Engel woke up feeling like an eye patch was covering his right eye: “I couldn’t see anything. Everything was dark. It was black.”
The doctor told Engel and his wife Shelley that it was a form of optic neuropathy — NAION, for short — an inoperable disease caused by tiny strokes that cut off blood flow to his eyes. When the doctor listed all the known causes, Shelley Engel specifically asked about Ozempic. “’We haven’t heard anything about it,’” she remembers the doctor telling her.
Seven months later, the newspaper JAMA Ophthalmology published research showing higher rates of NAION in diabetic patients taking Ozempic, or semaglutide, as the active ingredient is known. But neither Engel nor his doctor knew about it, so Engel continued to take weekly injections until his left eye turned black, just as the other had done the year before.
According to a recent Gallup analysis, more than one in ten Americans take a GLP-1 drug for weight loss, and one in seven have taken it at some point. Medications are prescribed for a growing number of conditions and cause a range of side effects.
Engel filed a lawsuit alleging that Ozempic’s manufacturer, Novo Nordisk, failed to warn patients and doctors about the risk of NAION.
His lawsuit is part of two major ongoing consolidated lawsuits alleging life-threatening or life-altering harm from GLP-1 drugs.
In a statement to NPR, Novo Nordisk spokespeople pointed out that subsequent research cast doubt on whether their drug GLP-1 caused NAION, for example, and said those cases were unfounded.
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The legal question before the courts depends in part on whether the GLP-1 drugs caused the harm. Observational data may show correlation – that people taking GLP-1 were perhaps more likely to suffer from this eye complication – but not causation. For this, a more detailed investigation is necessary.
When the JAMA Ophthalmology A study showed the correlation between NAION and diabetic patients on Ozempic or semaglutide, two medical groups criticized it. The American Academy of Ophthalmology and the North American Society of Neuro-Ophthalmology issued their own consumer clarifications, saying in part: “This is not the type of study that can show that the treatment caused NAION.” » The groups acknowledged there was a potential link, but more research would be needed to determine it. At this time, they are not recommending that patients stop taking their GLP-1.
A partial database
The Food and Drug Administration maintains an adverse events database. It is one of the only mechanisms that allows doctors, patients and pharmaceutical companies to report complications possibly related to pharmaceutical products. The reporting is mostly voluntary and the agency doesn’t verify the reports, but it’s a crucial first step in prompting regulators to do more research and potentially decide, for example, whether labels need to be updated.
In this database, NPR found more than 1,000 reports of GLP-1-related optic neuropathy since 2024. That’s nearly 190,000 reports regarding the drug during that time, most of which included minor gastrointestinal issues, dosing errors, or redness at the injection site.
Spokespeople for Novo Nordisk – maker of Ozempic and Wegovy – say NAION and other serious conditions are extremely rare in clinical trials. The company continues to collect and share data with the FDA on side effects reported with the drug since it came to market, but the agency has not requested changes to the warning labels. The FDA said in an email to NPR that it has undertaken its own study to evaluate the risks of NAION, is in the process of evaluating the claims, and will “determine the need for regulatory action” once its evaluation is complete.
The legal challenge
It’s not enough for today’s patients, says attorney Jonathan Orent, one of the lead court-appointed attorneys on the two major multi-district litigations alleging harm from GLP-1 drugs. He says Drugmakers should update their warnings to doctors and patients — as they have done in Europe — even if the conditions are rare.
This is necessary, Orent says, because “you will never have the population size necessary to detect rarer events in a clinical trial; you’ll never have the diversity of your actual population either.”
Orent’s cases include 247 plaintiffs with NAION and more than 4,000 with other serious digestive problems like pancreatitis or gallstones. “These warnings would have made a difference in the lives of real people,” he says. In an emailed statement, Eli Lilly, whose drug brands GLP-1 Mounjaro and Zepbound contain the active ingredient tirzepatide, said it would “vigorously defend itself against these allegations.”
NPR’s analysis of FDA adverse event data shows 1,928 reports of pancreatitis since 2024. (Other forms of pancreatitis are also listed, including 135 cases of necrotizing pancreatitis.)
Engel says he would have stopped taking Ozempic if he had known it could have put him at risk of blindness. Today he mourns everything he lost, including the ability to work or walk alone on the beach. “Being able to play ball…with my grandchildren, I can’t do those things anymore,” he said. “I will never, ever be able to see my wife’s beautiful face every day.”
Uncertainty in reporting
Obesity and diabetes are complex metabolic diseases that affect many organs and increase the risk of other diseases. This is part of what makes it difficult to determine whether the problems patients experience with GLP-1 drugs are caused by the drugs themselves.
That’s partly why Mohammed Ali, a diabetes specialist at Emory University, for example, did not report any of the three patients he treated who developed serious problems, such as pancreatitis or gallstones, while taking GLP-1, to the FDA’s adverse events database.
He said he wasn’t sure whether these problems were caused by the drugs themselves, although the timing was suspect.
“They may have had subclinical disease,” Ali says. “In other words, we didn’t know they had pre-existing pancreatitis or gallstones.”
Calls for poison control
The boom in online sales, where GLP-1s are widely marketed, also adds to the challenge, says pharmacist Robert Miller of the West Texas Poison Control Center.
Buying drugs on Instagram? “It’s definitely a new thing,” Miller says, and many sites offer little or no medical supervision to patients. That’s why, he says, more and more calls are coming into poison centers like his, with patients reporting vomiting or other side effects from GLP-1.
“So, is there even a doctor who is motivated to report side effects or someone who the patient feels they can report these side effects to?” he said.
These questions are now being asked in court, where plaintiffs like Engels are seeking damages from drugmakers.
But so does Shelley Engel wants more warnings about side effects, which she says could have helped her husband avoid blindness. She says her husband’s outgoing, vivacious personality has changed
“This could have been avoided if we knew,” she said.
NPR Correspondent Sydney Lupkin contributed to this report.
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