A Louisiana woman is suing the makers of Ozempic and Mounjaro, pharmaceuticals used to treat type-2 diabetes and obesity, alleging the drug companies failed to adequately warn of severe gastrointestinal side-effects that left her with permanent injuries.
Jaclyn Bjorklund filed the federal lawsuit Aug. 2 in the Western District of Louisiana. The complaint blames the drug companies for severe gastrointestinal events Bjorklund suffered from taking the drugs, which resulted in emergency room visits, vomiting whole food hours after eating and retching so intense that it caused some of the plaintiff’s teeth to fall out, according to the lawsuit.
The defendants, including Novo Nordisk and Eli Lilly and Co., downplayed the gastrointestinal risks associated with Ozempic and Mounjaro and failed to warn specifically of gastroparesis, a condition limiting muscular contractions in the stomach, and gastroenteritis, an inflammation of the stomach and intestines.
“... Symptoms (of gastroenteritis) include vomiting, nausea, diarrhea, stomach cramps, muscle aches, headaches and fever,” the complaint states. “Notably, vomiting and diarrhea can cause dehydration, which is the main complication of gastroenteritis, and which can lead to death.”
The lawsuit seeks more than $75,000 in compensatory damages for permanent personal injuries and health care costs, as well as punitive damages for the “reckless acts of the defendants who demonstrated a complete disregard and reckless indifference for the safety and welfare of the general public. …”
A Novo Nordisk spokeswoman noted that the class of drugs that includes Ozempic and Mounjaro – GLP-1 receptor agonists – has been given to type-2 diabetes patients for more than 15 years and to those suffering from obesity for eight years.
Semaglutide, the generic form of Ozempic, has been extensively examined in clinical studies worldwide that involved more than 9.5 million patient years of exposure, Natalia Salomao Abrahao said in an email to the Louisiana Record.
“While diabetes is a well-known risk factor (for gastroparesis), there are other risk factors that may increase the risk of gastroparesis such as overweight/obesity, gender (female), virus infection and nervous systems disease (Parkinson’s disease or multiple sclerosis),” Abrahao said.
In addition, gastrointestinal side-effects are well-known for the GLP-1 class of drugs, she said, adding that symptoms such as delayed stomach emptying, nausea and vomiting are listed as side-effects on semaglutide labeling.
“Patient safety is of utmost importance to Novo Nordisk,” Abrahao said. “... 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.”