A woman sues the maker of Ozempic and Mounjaro over serious GI problems

(CNN) — In a lawsuit filed Wednesday, a Louisiana woman claims she was seriously injured as a result of using Ozempic and Mounjaro prescribed by her doctor. These two injectable drugs were developed to manage diabetes and are popular for weight loss.

Jaclyn Bjorklund’s lawyer said the 44-year-old woman used Ozempic for more than a year until around July 2023 before starting Mounjaro. She sued the makers of the two drugs, Novo Nordisk and Eli Lilly, respectively, for failing to warn about the risk of serious gastrointestinal events from using the drugs.

“As a result of Defendant’s use of Ozempic and Mounjaro, Plaintiff suffered severe gastrointestinal distress, which resulted in serious and permanent bodily injury, pain, distress, and emotional distress, as well as medical expenses,” the complaint states.

Bjorklund suffers from “severe vomiting, stomach pain, GI heartburn, has been hospitalized multiple times for stomach issues, including trips to the emergency room, lost a tooth due to excessive vomiting, required additional medication to relieve the excessive vomiting, and Spit out the whole food “hours after eating,” he added.

The lawsuit says that the two companies, Novo Nordisk and Eli Lilly, “are aware of the association between the use of GLP-1 receptor agonists and the risk of serious gastrointestinal problems, such as gastroparesis and gastroenteritis. “

They “failed to disclose the information available about the relationship between the use of GLP-1 receptor agonists and the risk of serious gastrointestinal problems such as gastroparesis and gastroenteritis, rendering the drug’s warning insufficient, ’ the report continued.

The prescribing information for Ozempic and Mounjaro lists vomiting and abdominal pain as possible adverse effects, and the lawsuit does not say whether Bjorklund was diagnosed with gastroparesis (paralysis of the stomach).

The lawsuit seeks compensatory and punitive damages for past and future pain and suffering that Bjorklund will suffer, including health care costs and medical follow-up costs, as well as his attorneys’ fees and court costs.

Ozempic, de Novo, and the similar drug Wegovy use the same drug: semaglutide. Eli Lilly’s Mounjaro uses tirzepatide. These drugs and others in this family, including those like liraglutide, work by mimicking the body’s natural hormone GLP-1, which slows the passage of food through the stomach, helping people feel full for longer Belly feeling.

In addition to the new lawsuit, CNN also reported warnings for patients and doctors of gastroparesis and other side effects after taking Wegovy and Ozempic for weight loss or diabetes.

Gastric paralysis or slowed gastric emptying may cause nausea and vomiting in some patients. It can have a variety of causes, including diabetes, which is one of the reasons many people take medication. Women are known to be at greater risk for the disease.

Several doctors told CNN that more cases are coming to light as the drugs’ popularity soars. In a statement ahead of the lawsuit, the U.S. Food and Drug Administration (FDA) told CNN that it “received reports of gastroparesis caused by semaglutide and liraglutide, some of which indicated After the product, the adverse event has not resumed “reporting time”.

According to the prescribing information for Ozempic, the most common drug-related adverse events were nausea, vomiting, diarrhea, abdominal pain, and constipation. In the Drug Interactions section, it is stated that Ozempic delays gastric emptying and thus affects the absorption of oral medications.

The prescribing information for Mounjaro also states that nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia (dyspepsia), and abdominal pain are the most common adverse reactions, and that Mounjaro delays gastric emptying, which affects drug absorption.

Novo Nordisk, maker of Ozempic and Wegovy, responded to concerns about gastric paralysis in a statement to CNN ahead of the lawsuit, stating: “Gastrointestinal (GI) events are a well-known side effects. Most GI side effects of semaglutide are mild to moderate, and the short-acting GLP-1 is known to cause delayed gastric emptying, as seen in each of our GLP-1 receptor agonist drugs. indicated on the label. Symptoms of delayed gastric emptying, nausea, and vomiting are listed as side effects.”

In response to the new lawsuit, a Novo Nordisk spokesperson told The Hill: “Patient safety is of the utmost importance to Novo Nordisk. We constantly monitor the safety status of our products and work closely with authorities to ensure that patients safety, including adequate safety.” Information on the label regarding gastrointestinal side effects.

In a statement obtained by The Hill, a spokesperson for Eli Lilly, maker of Mounjaro, said patient safety is the company’s “top priority” and that they “actively participate in monitoring, evaluating and reporting safety information for all.” . Our drug,” the news outlet reported.

CNN has reached out to Novo Nordisk and Eli Lilly for comment on the lawsuit.

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