Corrections & Clarifications: An earlier version of this story misspelled Dr. Mohit Sodhi’s name.
Dana Filmore was terrified of taking Ozempic.
Her fear of needles made the idea of injecting herself in the stomach with the drug, which can only be administered under the skin, seem near-impossible.
But the antidiabetic pills Filmore was taking weren’t enough to bring her blood sugar down to a healthy level. Her doctor told her that Ozempic, a medication approved by the U.S. Food and Drug Administration to treat Type 2 diabetes, could help.
So Filmore, a 55-year-old grandmother of seven and account coordinator from Columbus, Ohio, bit the bullet.
Now more than three years later, Filmore’s doctor has diagnosed her with gastroparesis, or stomach paralysis – a potential side effect of the drug. Six months after stopping the injections, Filmore still can’t keep food down.
Normally, the stomach contracts to propel food through the digestive tract. With gastroparesis, the stomach muscles are paralyzed, so food lingers in the stomach for longer than it should, which results in vomiting or diarrhea.
“You never know what will set it off,” said Filmore, who says she has to run to the bathroom within minutes of starting a meal.
She’s one of thousands of plaintiffs across the country claiming in a federal lawsuit that Ozempic, Mounjaro and other popular drugs prescribed for diabetes and obesity harmed their health, and that the pharmaceutical companies that manufactured them failed to warn patients of their risks.
The suit against two manufacturers, Novo Nordisk and Eli Lilly, was filed this year. It’s in the discovery process and may go to trial in 2025.
Central to the lawsuit is the claim that Ozempic caused plaintiffs’ gastroparesis.
“We represent over 3,000 people that are from all walks of life,” said Andrew Van Arsdale, founding attorney of the AVA Law Group, the firm representing Filmore and other plaintiffs.
In response, Novo Nordisk, the Danish pharmaceutical company that makes Ozempic, maintains that the lawsuit is “without merit,” according to Jamie M. Bennett, a spokesperson for the company.
“We intend to vigorously defend against these claims,” he said.
‘Scared to eat’
Filmore said that her nausea and lack of bowel control, which began in the last six months that she was on Ozempic, forced her to burn through her vacation time to try and recover.
Though Filmore’s since been able to return to her job, where she manages over a dozen technicians at a mechanical company, her 35-minute commute poses a daily struggle.
“Halfway to work, I have to stop into a restaurant or to a gas station,” said Filmore. “My stomach doesn’t give me that long to really decide where I’m going to go.”
When she couldn’t make it to the bathroom, she’s had to turn the car around, return home, change her pants and shower. “How do you explain that to your boss?”
Filmore’s stomach has her scared to eat, so her diet now mostly consists of broth, soup, Jell-O and protein shakes. She doesn’t feel that she’s getting the nutrients she needs, but not having a full meal is the only way that she can avoid running to the restroom.
“The solids are really difficult on me,” she said. “My body just rejects it.”
But Filmore said what’s most devastating is that she took the drug to lengthen her time with her family, but it’s had the opposite effect.
Filmore, who raised her kids as a single mom, remembers shuttling her four kids to and from football, basketball and cheerleading practice. Her kids are now adults, some with children of their own, and Filmore wants to be just as involved in their lives but can’t because she’s constantly worried about being close enough to a bathroom.
“It’s just very painful that I can’t be involved like I want to,” said Filmore, who’s missed her grandkids’ Friday night games and school plays since her diagnosis.
“I come home and stay in my room because I feel like, what else is there to do?”
Does Ozempic cause gastroparesis?
Representatives of Novo Nordisk deny that Ozempic has caused gastroparesis in Filmore and other plaintiffs.
The known risks and benefits of semaglutide and liraglutide − the active ingredients in weight loss drugs − are “described in their FDA-approved product labeling,” Bennett said. Semaglutide is the active ingredient in Ozempic, while liraglutide is the active ingredient in medications similar to Ozempic. Both fit into a class of drugs known as GLP-1 agonists, which mimic the body’s natural hormones to lower blood sugar and suppress appetite.
The FDA’s most up to date warning label for Ozempic notes that clinical trials for the drug caused some participants to experience gastrointestinal reactions such as nausea and diarrhea. However, it does not list gastroparesis, a condition that is often permanent and incurable, as a potential side effect.
“Novo Nordisk stands behind the safety and efficacy of all of our GLP-1 medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional,” said Bennett.
Indianapolis-based pharma company Eli Lilly was also named in the lawsuit for failing to warn patients about the risks of Mounjaro, another drug developed to manage Type 2 diabetes by slowing digestion and reducing appetite.
“Patient safety is Lilly’s top priority,” said company spokesperson Jared Shapiro. “Our FDA-approved label clearly warns that Mounjaro may be associated with gastrointestinal adverse reactions, sometimes severe.”
Unlike Ozempic, Mounjaro’s FDA warning label mentions that the drug has not been studied in those with severe gastrointestinal disease and is not recommended for those patients. Still, according to Shapiro, the company is “vigorously defending” against the claim that the drug caused gastroparesis.
Ozempic vs. Mounjaro? There’s a clear winner for weight loss, study finds
In a study of drugs including Ozempic and Mounjaro, Canadian researchers found in 2023 that taking the drugs was associated with a higher risk of serious conditions such as gastroparesis and pancreatitis.
Dr. Mohit Sodhi, first author for the study, which was published by the Journal of the American Medical Association, said the drug may have caused gastroparesis in the patients represented in the lawsuit.
“One of the ways Ozempic helps with weight loss is that it delays gastric emptying and decreases intestinal motility,” Sodhi said. “It is possible that in some patients this side effect is so severe that it causes gastroparesis.”
While further studies are needed to validate his research, Sodhi said that his study found that the rate of gastroparesis in patients using drugs like Ozempic was around 1%. Still, with millions of Americans on these medications, 1% could translate to hundreds of thousands of patients being affected by gastroparesis, he said.
Dr. Sun Kim, a board-certified endocrinologist at Stanford Health Care who treats patients with Type 2 diabetes and obesity, said she always mentions the risk of developing gastroparesis to her patients before prescribing a drug like Ozempic. Still, determining the cause of gastroparesis is difficult, Kim says, because it’s also a side effect of Type 2 diabetes, especially for patients who’ve had diabetes for a while.
In her practice, a patient’s side effects usually stop after stopping the drug, which hasn’t been the case with patients like Dana Filmore.
“The lingering question is, could it cause more permanent effects?” Kim said. “There’s no definitive answer on this.”
Ozempic side effects reported to FDA exceeds 20,000 cases
More than 21,638 cases of side effects of Ozempic have been reported to the FDA since 2018, according to the agency’s Adverse Event Reporting System.
That’s higher than usual for a drug that’s only recently reached the market, according to Sodhi, but given the drug’s status as a household name, he thinks that people are more likely to report side effects than they are for other drugs.
Gastrointestinal conditions such as gastroparesis make up 43% of reports – though symptoms like nausea were more commonly reported than severe gastrointestinal illness like gastroparesis. This isn’t surprising, according to Kim, who says that clinical trials of Ozempic showed that the top side effect is gastrointestinal.
FDA spokesperson Chanapa Tantibanchachai said that the FDA is aware of the reports but awaiting evidence that shows whether the drug caused gastroparesis.
It’s unclear whether drugs like Ozempic contributed to gastroparesis when used in patients with Type 2 diabetes, she said. “Gastroparesis can be a complication of diabetes that is related to long-standing or poorly controlled disease.”
Regardless of the lawsuit’s outcome, Filmore wants others to reconsider taking the drug that she believes upended her life.
“I was always the mom that was involved,” recalled Filmore. “I couldn’t imagine doing that now.”
(This story has been updated to correct a misspelling.)
