A woman is suing the makers of Ozempic and Mounjaro, alleging the companies have "downplayed" the severity of side effects caused by the medications and asserting she was “severely injured” from taking them.
The self-injected drugs are approved to treat Type 2 diabetes, but many people use them off-label for weight loss, a famous side effect.
Is there a lawsuit over Ozempic side effects?
The lawsuit, filed Aug. 2, 2023, in the U.S. District Court for the Western District of Louisiana, is the first to allege the medications can cause gastrointestinal injuries, NBC News reported.
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Jaclyn Bjorklund of Louisiana accuses Novo Nordisk, the maker of Ozempic, and Eli Lilly, which makes Mounjaro, of failing to warn — or adequately warn — of all the possible adverse side effects from using the medications, including the risk of gastroparesis, also known as “paralyzed stomach.”
Bjorklund, 44, was diagnosed with Type 2 diabetes in 2017 and used Ozempic for more than one year, then stopped and switched to Mounjaro in July 2023 — with both drugs prescribed by her doctors to control her blood sugar, according to court papers.
As a result, she suffered from “severe gastrointestinal events,” including severe vomiting, throwing up food hours after eating, stomach pain, gastrointestinal burning, hospitalizations for stomach issues and teeth falling out because of excessive vomiting, the lawsuit states.
Bjorklund hasn’t yet been diagnosed with gastroparesis, Paul Pennock, an attorney for the firm representing the woman, told reporters on Aug. 2. But he noted her symptoms are “indicative of” the condition.
A spokesperson for Eli Lilly did not respond to an NBC News request for comment on the lawsuit. Natalia Salomao, a spokesperson for Novo Nordisk, said gastroparesis is a known risk for people with diabetes.
“Patient safety is of utmost importance to Novo Nordisk,” she said. “We recommend patients take these medications for their approved indications and under the supervision of a healthcare professional.”
Pennock dismissed suggestions that Bjorklund’s condition was caused by her diabetes on a call with reporters on Aug. 2.
The term “gastroparesis” doesn’t appear in the prescribing information for Ozempic or Monjauro, but “delays gastric emptying” appears on both of the drugs’ labels, NBC News reported. Gastric emptying can affect the way other medications are absorbed by the body.
The U.S. Food and Drug Administration declined to comment on the lawsuit.
What is stomach paralysis? Gastroparesis symptoms
Gastroparesis is a disorder that slows or stops the movement of food from the stomach to the small intestine even though there are no blockages in the digestive system, according to the National Institute of Diabetes and Digestive and Kidney Diseases.
Symptoms include:
- feeling full soon after starting a meal and long after
- nausea
- vomiting
- excessive bloating and belching
- pain in the upper abdomen
- heartburn
- poor appetite
Diabetes is the most common known underlying cause of the condition, which is also called delayed gastric emptying, the institute noted.
Medications that delay stomach emptying may also cause gastroparesis, the American College of Gastroenterology notes. Ozempic and Mounjaro both delay gastric emptying, according to their prescribing information, but gastroparesis is not included among the possible adverse reactions for either drug.
As TODAY.com previously reported, the active ingredient in Ozempic and Mounjaro — semaglutide and tirzepatide, respectively — are both in a class of drugs called GLP-1 agonists and mimic the effects of a hormone the body releases when people eat food.
The medications slow down stomach emptying, which slows down the absorption of calories and may contribute to the feeling of fullness — one of the ways this helps people lose weight, doctors say.
In a statement to NBC News, FDA spokesperson Chanapa Tantibanchachai said it's unclear whether the GLP-1 medications contribute to the occurrence of gastroparesis.
Dr. Shauna Levy, a specialist in obesity medicine and the medical director of the Tulane Bariatric Center in New Orleans, told NBC News the drugs could cause gastroparesis, but the problem could also be caused by another undiagnosed illness or the patient’s diabetes, and then made worse by the medications.
“As a provider, I’m not worried about this being a common problem,” Levy said.
What has the FDA warned Ozempic users about?
In May 2023, the FDA warned it had received “adverse event reports” after patients used compounded semaglutide, a copycat treatment from compounding pharmacies.
The agency said some compounders may be using salt forms of semaglutide, which are different from the active ingredient used in Ozempic and Wegovy. Products containing these salts have not been shown to be safe and effective, the FDA warned.
Novo Nordisk, says it does not sell semaglutide for the purposes of compounding with other products.
Does Ozempic make you sick? What are the biggest side effects of Ozempic?
The most common side effects of Ozempic include nausea, diarrhea, vomiting, stomach pain and constipation, according to Novo Nordisk.
It may cause serious side effects including pancreatitis, changes in vision, low blood sugar, kidney problems, serious allergic reactions and gallbladder problems.
Mounjaro has a similar side effect profile, but its list of serious side effects also includes severe stomach problems, according to Eli Lilly.
The FDA will continue to monitor for any potential adverse events from the medications, Tantibanchachai said.
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