Ongoing lawsuits allege GLP-1s can cause serious harm.
asserted
GLP-1s → ongoe → harm
But we don't know how often
Todd Engel had operated heavy machinery, like forklifts and rubber-tire loaders, around warehouses and highways in suburban Maryland for four decades.
In early 2023, Engel's doctor put him on Ozempic, a GLP-1, for diabetes.
asserted
doctor → know → diabetes
That winter, on New Year's Eve, Engel woke up feeling as if a patch covered his right eye: "I couldn't see anything.
asserted
I → wake → anything
The doctor told Engel and his wife Shelley it was a form of optic neuropathy — NAION, for short – an inoperable condition caused by tiny strokes that cut off blood flow to his eye.
asserted
that → tell → eye
When the doctor listed all known causes, Shelley Engel specifically asked about Ozempic.
asserted
Engel → list → Ozempic
"'We have heard nothing about that,'" she recalls the doctor telling her.
asserted
doctor → hear → her
Seven months later, the journal JAMA Ophthalmology did publish research showing higher rates of NAION among diabetic patients taking Ozempic, or semaglutide, as the active ingredient name is known.
asserted
name → publish → Ozempic
But neither Engel nor his doctor were aware, so Engel kept taking weekly shots until his left eye went black, just as the other had done the year prior.
asserted
other → keep → shots
More than one in 10 Americans are taking a GLP-1 drug for weight loss, according to a recent Gallup analysis, and one in seven has taken them at some point.
uncertain
seven → take → point
The drugs are prescribed for a growing number of conditions and come with a range of side effects.
asserted
drugs → prescribe → effects
Engel has filed a lawsuit alleging the maker of Ozempic, Novo Nordisk, failed to warn patients and doctors about the risk of NAION.
asserted
maker → file → NAION
His suit is part of two main ongoing consolidated lawsuits alleging life-threatening or life-altering harm from GLP-1 drugs.
asserted
suit → allege → drugs
In a statement to NPR, spokespeople for Novo Nordisk pointed to subsequent research casting doubt on whether their GLP-1 drug causes NAION, for example, and said the cases are without merit.
asserted
cases → point → merit
The legal question before the courts hinges in part on whether the GLP-1 drugs caused the harm.
asserted
drugs → hinge → harm
Observational data can show correlation — that people taking GLP-1s were perhaps more likely to have this eye complication occur — but not causation.
asserted
complication → show → GLP-1s
For that, more detailed investigation is needed.
asserted
investigation → need → that
When the JAMA Ophthalmology study came out showing the correlation between NAION and diabetic patients on Ozempic or semaglutide, two medical groups critiqued it.
asserted
groups → come → it
The American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society issued their own consumer clarification saying, in part: "This is not the type of study that can show the treatment caused NAION."
asserted
treatment → issue → NAION
The groups did acknowledge there is a potential link, but further research would be necessary to determine that.
asserted
research → acknowledge → that
For now, they don't recommend that patients stop taking their GLP-1s.
asserted
patients → recommend → GLP-1s
A partial database
The Food and Drug Administration keeps a database tracking adverse events.
asserted
Administration → keep → events
It's one of the only mechanisms for doctors, patients and drug companies to submit reports of complications possibly linked to pharmaceuticals.
uncertain
doctors → submit → pharmaceuticals
Reporting is mostly voluntary and the agency does not verify the reports, but it is a crucial first step to prompt regulators to do further research and eventually decide, for example, if labels need updating.
asserted
labels → verify → updating
In this database, NPR found more than 1,000 reports of optic neuropathy linked to GLP-1s since 2024.
asserted
NPR → find → 2024
That's out of nearly 190,000 reports made about the drug over that period, most of which included minor gastrointestinal issues, dosing errors or injection site redness.
asserted
most → make → issues
Spokespeople for Novo Nordisk — maker of Ozempic and Wegovy — say NAION and other serious conditions are exceedingly rare in clinical trials.
asserted
NAION → say → trials
The company continues to collect and share data with the FDA about the side effects reported with the drug since going to market, but the agency has not requested warning-label changes.
asserted
agency → continue → changes
The FDA said in an email to NPR it has undertaken its own study to assess NAION risks, and is assessing claims and will "determine the need for regulatory action" once its assessment is complete.
uncertain
assessment → say → action
That is not sufficient for patients today, says attorney Jonathan Orent, a lead court-appointed attorney on the two major multi-district litigation lawsuits alleging harms from GLP-1 drugs.
asserted
Orent → say → drugs
He says drug makers ought to update warnings to doctors and patients — as they have in Europe — even if the conditions are rare.
asserted
conditions → say → Europe
It's necessary, Orent says, because "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."
asserted
you → say → population
Orent's cases include 247 plaintiffs with NAION, and more than 4,000 with other serious digestive conditions like pancreatitis or gall stones.
asserted
cases → include → pancreatitis
"These warnings would have made a difference in the lives of real people," he argues.
asserted
he → make → people
In an emailed statement, Eli Lilly, whose GLP-1 drug brands Mounjaro and Zepbound contain the active ingredient tirzepatide said it will "vigorously defend against these claims."
uncertain
it → email → claims
NPR's analysis of the FDA's adverse events data show 1,928 reports of pancreatitis since 2024.
asserted
analysis → show → 2024
(Other forms of pancreatitis are also listed, including 135 cases of necrotizing pancreatitis.)
asserted
forms → list → pancreatitis
Engel says he would've stopped taking Ozempic had he known that it might have put him at risk for blindness.
uncertain
it → say → blindness
Now, he mourns all he's lost, including the ability to work or walk the beach unaided.
asserted
he → mourn → beach
"Being able to play ball … with my grandchildren, I can't do these things anymore," he says.
asserted
he → play → things
"I will never, never be able to see my wife's beautiful face every day.
asserted
I → see → face
…and 14 more, not listed.
The Aporia
