As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users.
Case in point is a claim from a Louisiana woman who is suing both companies, alleging her use of Novo’s Ozempic (semaglutide) and Lilly’s Mounjaro caused her to vomit so much that some of her teeth have fallen out.
Jaclyn Bjorklund, 44, who used Ozempic for more than a year and then switched to Mounjaro, says the companies failed to warn patients of “severe gastrointestinal events” that can be caused by using the injected drugs.
The lawsuit claims that Bjorklund has suffered from “severe vomiting, stomach pain, gastrointestinal burning,” and has been hospitalized for stomach issues on “several” occasions.
The prescribing labels for Ozempic and Mounjaro say the drugs “delay gastric emptying” and warn of the risk of gastrointestinal adverse reactions.
“Gastrointestinal (GI) events are well-known side effects of the GLP-1 class,” a Novo Nordisk spokesperson said in an email. “For semaglutide, the majority of GI side effects are mild to moderate in severity and of short duration.”
Bjorklund’s lawsuit also says the medications can cause gastroparesis (stomach paralysis) and gastroenteritis (stomach inflammation), conditions that are not included on label warnings. The suit does not declare whether Bjorklund suffered from these disorders.
In its statement, Novo said risk factors of gastroparesis include obesity, viral infections and nervous system disorders. Women also are more susceptible, Novo added.
Bjorklund is pursuing damages for past and future pain and suffering. She also seeks medical costs along with attorney fees and court costs.
With the increased use of these GLP-1 treatments—and as safety issues receive closer scrutiny—the companies have been quick to remind the public that GLP-1 drugs have been on the market for 15 years for Type 2 diabetes and for eight years for obesity.
“Semaglutide has been extensively examined in robust clinical development programs, large real world evidence studies and has cumulatively over 9.5 million patient years of exposure,” Novo added.
Both companies said patient safety is a top priority.
“We actively engage in monitoring, evaluating and reporting safety information for all of our medicines,” a Lilly spokesperson said in an email.
Last month, in response to two reports of users having suicidal thoughts, the European Medicines Agency said it would review Novo’s Ozempic and Saxenda to determine whether there was a causal relationship between their use and the adverse events. The U.K.'s drug regulator has also kicked off a parallel review.