A Louisiana woman has filed a lawsuit alleging that Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro did not have warnings about the risk of severe gastrointestinal problems.
Pictured: Gavel and scales of justice/iStock, BrianAJackson
A Louisiana woman is suing Novo Nordisk and Eli Lilly, respective manufacturers of Ozempic and Mounjaro, alleging the drugmakers failed to warn users of the medications about the risk of severe gastrointestinal issues.
The suit claims the companies “downplayed the severity of the gastrointestinal events caused by Ozempic and Mounjaro” and never warned patients about the possibility of gastroparesis—a slowdown or stopping of the digestive system—or gastroenteritis, an infection and inflammation of the digestive system.
The plaintiff, 44-year-old Jaclyn Bjorklund, took Ozempic for over a year before switching to Mounjaro, according to the lawsuit. It alleges that she suffered from “severe gastrointestinal events” including being hospitalized for stomach issues and going to the emergency room, as well as “teeth falling out due to excessive vomiting, requiring additional medications to alleviate her excessive vomiting, and throwing up whole food hours after eating.”
The two drugs are a part of a class of drugs known as GLP-1 receptor agonists, which stimulate insulin production and reduce glucose production, that are used to treat Type 2 diabetes. While different drugs in the class are approved for treatment of both obesity and diabetes, many only approved for diabetes are also prescribed off-label for weight loss.
The lawsuit alleges that while the companies “acknowledge that gastrointestinal events are well known side effects of the GLP-1 class,” they nevertheless never warned patients of the risk of more severe gastrointestinal events, such as gastroparesis or gastroenteritis.
The labels of both medications do note the risk of delayed gastric emptying, among other stomach problems such as nausea, vomiting, and diarrhea, but do not include an explicit warning of gastroparesis.
The allegations come on the heels of an investigation into possible suicidal ideation and self-harm risk associated with the class of drugs. The UK’s Medicines and Healthcare products Regulatory Agency announced an investigation on July 26, shortly after The European Medicines Agency expanded its own investigation into GLP-1 receptor agonists.
A Novo Nordisk spokesperson reportedly said in a statement that gastrointestinal events are “well-known side effects” of GLP-1 receptor agonists, and that Ozempic’s side effects are usually “mild to moderate in severity and of short duration.” The spokesperson added: “We are continuously monitoring the safety profile of our products and collaborate closely with authorities to ensure patient safety, including adequate information on gastrointestinal side effects in the label.”
A Lilly spokesperson reportedly said in a statement that patient safety is the company’s “top priority” and that it “actively [engages] in monitoring, evaluating, and reporting safety information” for its medications.
The law firm that filed the lawsuit against Novo Nordisk and Lilly on behalf of Bjorklund told CBS News it is investigating 400 other inquiries from clients across 45 states.
Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.
