A woman is suing the makers of popular drugs Ozempic and Mounjaro over claims that they failed to warn patients about the severity of certain gastrointestinal side effects.
Jaclyn Bjorklund, 44, of Louisiana, alleged in the lawsuit that Novo Nordisk and Eli Lilly "downplayed the severity of gastrointestinal events caused by Ozempic and Mounjaro, never, for example, warning of the risk of gastroparesis ("paralyzed stomach") or gastroenteritis."
Bjorklund, who used Ozempic for more than a year before switching to Mounjaro last month, alleged she was "severely injured as a result" of using both drugs, the suit stated.
Ozempic and Mounjaro are injectable prescription medications that are used to improve blood sugar control in adults with Type 2 diabetes in addition to diet and exercise. However, they have surged in popularity after celebrities and other high-profile figures touted their weight loss effects.
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Novo Nordisk manufactures Ozempic, the brand name for semaglutide, and Eli Lilly manufactures Mounjaro, the brand name for tirzepatide.
The lawsuit alleges both drugmakers "knew of the association between the use of GLP-1 receptor agonists and the risk of developing severe gastrointestinal issues, including gastroparesis and gastroenteritis," and that their "failure to disclose information that they possessed regarding the association between the use of GLP-1 receptor agonists and the risk of developing severe gastrointestinal issues, including gastroparesis and gastroenteritis, rendered the warnings for this medication inadequate."
Gastroparesis is a condition that slows or stops the movement of food from the stomach to the small intestine, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The disorder is also called delayed gastric emptying.
Symptoms include cause nausea, vomiting, abdominal pain, abdominal bloating, a feeling of fullness after eating just a few bites and vomiting undigested food, according to the Mayo Clinic. There is no cure for the condition, the Mayo Clinic said.
Viral gastroenteritis – otherwise known as stomach flu – is an intestinal infection and causes symptoms such as watery diarrhea, stomach cramps, nausea or vomiting and sometimes fever, according to the Mayo Clinic. However, the suit claims that "gastroenteritis may also be caused by ingesting medications."
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Bjorklund claims she suffered "severe gastrointestinal events, which resulted in, for example, severe vomiting, stomach pain, gastrointestinal burning," as well as being hospitalized for stomach issues on several occasions including visits to the emergency room after using the medications.
The suit also claimed that Bjorklund's teeth started "falling out due to excessive vomiting, requiring additional medications to alleviate her excessive vomiting" and that she would throw up "whole food hours after eating."
Novo Nordisk told FOX Business that gastrointestinal events "are well-known side effects of the GLP-1 class." Additionally, the majority of gastrointestinal side effects – for semaglutide in particular – "are mild to moderate in severity and of short duration."
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"GLP-1’s are known to cause a delay in gastric emptying, as noted in the label of each of our GLP-1 RA medications," the drugmaker said. "Symptoms of delayed gastric emptying, nausea and vomiting are listed as side effects."
While diabetes is a well-known risk factor of 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)," the Novo Nordisk said.
Both Novo Nordisk and Lilly reiterated that they are continually monitoring the safety of the drugs.
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"Patient safety is Lilly’s top priority, and we actively engage in monitoring, evaluating and reporting safety information for all our medicines," a spokesperson for Lilly told FOX Business.
Novo said it's "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."
