A Louisiana woman is suing the makers of two type 2 diabetes drugs used off-label for obesity, saying they failed to adequately warn about the risk of severe stomach problems.
Pennock filed the lawsuit Wednesday on behalf of Jaclyn Bjorklund, 44, NBC News reported.
The lawsuit against Novo Nordisk and Eli Lilly claims Bjorklund was “severely injured” after taking the two diabetes drugs, which are part of a new class of medication called GLP-1 agonists.
Pennock said she is suffering “persistent” vomiting and severe gastroparesis, also known as stomach paralysis.
Gastroparesis slows or stops food from moving out of the stomach and into the small intestines. It can be caused by underlying medical issues, including diabetes, according to the American College of Gastroenterology. Infections and some medication can also cause it.
The GLP-1 agonists slow food’s movement and have been found to cause some GI issues in clinical trials. Those are listed as side effects on the drug labels.
Both Ozempic and Mounjaro have the phrase “delays gastric emptying” on their prescribing information, though they don’t specifically use the word “gastroparesis,” NBC News reported.
A U.S. Food and Drug Administration spokeswoman said it was unclear whether the GLP-1 medications contribute to gastroparesis.
“If newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence,” spokeswoman Chanapa Tantibanchachai said in a statement.
Eli Lilly did not respond to an NBC News request for comment, and a Novo Nordisk spokeswoman said the company was unaware of the lawsuit.
“Patient safety is of utmost importance to Novo Nordisk,” said spokeswoman Natalia Salomao. “We recommend patients take these medications for their approved indications and under the supervision of a health care professional.”
There’s more about GLP-1 agonists and weight loss at the Mayo Clinic.
SOURCE: NBC News
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