Novo Nordisk and Eli Lilly are facing a lawsuit from a Louisiana woman who claims the pharmaceutical companies failed to warn patients about health risks associated with their popular Type 2 diabetes drugs.

Filed Aug. 2 in United States District Court, Western District of Louisiana, the 26-page complaint accuses Novo Nordisk and Eli Lilly, the respective makers of Ozempic and Mounjaro, of downplaying “the severity of gastrointestinal events” caused by the injectable prescription medications, including severe gastroparesis, also known as stomach paralysis, as well as “persistent” vomiting.

According to the lawsuit, the 44-year-old woman took semaglutide Ozempic for more than a year before switching to tirzepatide Mounjaro last month and suffered from numerous health problems, ranging from stomach pain to gastrointestinal burning to loss of teeth from excessive vomiting.

Although the labels for both medications note that they could delay gastric emptying and cause a range of stomach issues – such as nausea, diarrhea, abdominal pain, constipation and vomiting – there is no warning about the risk of stomach paralysis and gastroenteritis. In her complaint, the woman said she believes Novo Nordisk and Eli Lilly were aware of the link between those medical conditions and their drugs, but chose to ignore it and not disclose to patients.

She is seeking compensatory damages for pain and suffering for injuries, health care costs and medical monitoring, as well as punitive damages “for the wanton, willful, fraudulent, reckless acts” of the companies “who demonstrated a complete disregard and reckless indifference for safety and welfare of the general public,” according to the complaint.

‘Well-known side effects’

Ozempic and Mounjaro, which belong to a class of drugs called GLP-1 receptor agonists, help people with Type 2 diabetes manage their blood sugar levels. Recently, the drugs have grown in popularity due to off-label use for weight loss.

A spokesperson for Novo Nordisk, whose U.S. headquarters is in Plainsboro, said in a statement to NJBIZ that gastrointestinal events are “well-known side effects” of this class of medications and the majority of issues “are mild to moderate in severity and of short duration.”

“GLP-1 has been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for 8 years, including Novo Nordisk GLP-1 products such as semaglutide and liraglutide that have been on the market for more than 10 years,” the statement said. “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.”

The company went on to note that GLP-1 products are known “to cause a delay in gastric emptying, as noted in the label of each of our GLP-1 RA medications” and that the symptoms it could lead to – nausea and vomiting – are listed as Ozempic side effects.

Novo Nordisk also said that diabetes is a “well-know risk factor” for gastroparesis, which is a clinical syndrome characterized by delayed gastric emptying in the absence of physical stomach obstruction. Additionally, the statement said, several other factors 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 company went on to say that patient safety “is of the utmost importance” and recommended patients take these medications for their approved indications and under the supervision of a health care professional.

Novo Nordisk 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 representative for Indianapolis, Ind.-headquartered Eli Lilly did not immediately respond to a request for comment regarding the lawsuit.

Across the pond

The filing comes about a month after European regulators said they expanded an investigation into the risk of suicidal thoughts among patients taking GLP-1 receptor agonists, including Novo Nordisk’s popular weight loss and diabetes drugs, to include more medications in the class.

After receiving reports from Icelandic health officials about three cases of suicidal thoughts and self-injury in patients taking Ozempic and Saxenda, the European Medicines Agency (EMA) began looking into whether there’s a connection between the incidents and the active ingredients in the medicines – semaglutide and liraglutide.

Since launching the probe July 3, the EMA’s safety committee has uncovered 150 more adverse event reports, prompting the agency to broaden the scope of the review to include other GLP-1 treatments.

In a statement, the EMA stressed that it is “not yet clear whether the reported cases are linked to the patients’ underlying conditions or other factors,” but noted that the medications “are widely used,” with an exposure of more than 20 million patients annually. Additionally, suicidal behavior is not listed as a side effect in the EU product information for any GLP-1 receptor agonists.

However, the prescribing information for Wegovy in the U.S. notes that suicidal ideation and behavior has been reported in clinical trials for other weight management products and says that patients on Wegovy should be monitored for depression and suicidal thoughts or behavior.