Mario Tama/Getty Images
LOS ANGELES, CALIFORNIA – APRIL 17: In this photo illustration, boxes of the diabetes drug Ozempic rest on a pharmacy counter on April 17, 2023 in Los Angeles, California. Ozempic was originally approved by the FDA to treat people with type 2 diabetes — who risk serious health consequences without medication. In recent months, there has been an increase in demand for Ozempic, or semaglutide, due to its weight loss benefits, leading to shortages. Some doctors prescribe Ozempic off-label to treat obesity. (Photo illustration by Mario Tama/Getty Images)
In a lawsuit filed Wednesday, a Louisiana woman claims she suffered serious injuries because of her use of Ozempic and Mounjaro, which were prescribed by her doctor. The two injectable medications, developed to manage diabetes, have gained popularity for weight loss.
Lawyers for Jaclyn Bjorklund claim the 44-year-old woman used Ozempic for more than a year until around July 2023 and then started using Mounjaro. She is suing the manufacturers of both drugs, Novo Nordisk and Eli Lilly, for not warning about the risk of serious gastrointestinal events that can be caused by taking the drugs.
“As a result of Defendant’s use of Ozempic and Mounjaro, Plaintiff suffered serious gastrointestinal events and, as a result, suffered serious and permanent personal injury, pain, suffering and emotional distress and incurred medical expenses.” claims the lawsuit.
Bjorklund has suffered from “severe vomiting, abdominal pain, stomach burning, being hospitalized for stomach problems on multiple occasions, including visits to the emergency room, teeth falling out due to excessive vomiting, requiring additional medication to relieve her excessive vomiting and throwing up whole food hours after eating,” it adds.
The lawsuit alleges that the two companies, Novo Nordisk and Eli Lilly, “knew of the association between the use of GLP-1 receptor agonists and the risk of developing serious gastrointestinal problems, including gastroparesis and gastroenteritis.”
Their “failure to disclose information they possessed about the association between the use of GLP-1 receptor agonists and the risk of developing serious gastrointestinal problems, including gastroparesis and gastroenteritis, made the warnings for this medication inadequate,” it continues.
Vomiting and abdominal pain are both listed as possible side effects on prescribing information for Ozempic and Mounjaro, and the lawsuit does not say whether Bjorklund was diagnosed gastroparesis — stomach paralysis.
The lawsuit seeks compensatory and punitive damages for past and future pain and suffering that Bjorklund will suffer, including expenses for health care and medical monitoring as well as her legal fees and legal costs.
Novo’s Ozempic and a similar drug, Wegovy, use the same drug, semaglutide. Eli Lilly’s Mounjaro uses tirzepatid. These and other drugs in this family, which include drugs such as liraglutide, work by mimicking a hormone naturally produced by the body, GLP-1, which slows the passage of food through the stomach, helping people feel fuller for longer .
Separate from the new lawsuit, CNN has reported warnings from patients and doctors about gastroparesis and other side effects after taking Wegovy and Ozempic for weight loss or diabetes.
Stomach paralysis or slowing down of the stomach from emptying can lead to nausea and vomiting in some patients. It can have many causes, including diabetes, which is one reason many people take drugs. Women are known to be at higher risk for the condition.
Doctors told CNN that more cases are coming to light as the drugs’ popularity has increased. In a statement before the trial, the US Food and Drug Administration told CNN that it had “received reports of gastroparesis with semaglutide and liraglutide, some of which documented the adverse event as not recovering after discontinuation of the respective product at the time of the report.”
Ozempic’s prescription Information says the most common side effects related to the drug are nausea, vomiting, diarrhea, abdominal pain and constipation. Under a section on drug interactions, it states that Ozempic delays gastric emptying, which can affect the absorption of oral medications.
Mounjaro’s prescription Information also says that nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain are the most common side effects, and that Mounjaro delays gastric emptying, which can affect drug absorption.
In a statement to CNN responding to concerns about gastric paralysis ahead of the trial, Novo Nordisk, the maker of Ozempic and Wegovy, said, “Gastrointestinal (GI) events are well-known side effects of the GLP-1 class. For semaglutide, the majority of The GI side effects are mild to moderate in severity and of short duration. GLP-1s are known to cause a delay in gastric emptying, as noted on the label of each of our GLP-1 RA medications. Symptoms of delayed gastric emptying, nausea and vomiting are listed as side effects.”
In response to the new lawsuit, a spokesperson for Novo Nordisk told The Hill, “Patient safety is of utmost importance to Novo Nordisk. “We continuously monitor the safety profile of our products and work closely with authorities to ensure patient safety, including adequate information about gastrointestinal side effects on label.”
In a statement obtained by The hilla spokesman for Eli Lilly, maker of Mounjaro, said patient safety is the company’s “top priority” and that it is “actively engaged in monitoring, evaluating and reporting safety information for all of our drugs,” the news outlet reported.
CNN has contacted both Novo Nordisk and Eli Lilly for comment on the lawsuit.