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Ozempic and Mounjaro Weight Loss Lawsuit


Ozempic lawsuits allege Novo Nordisk failed to warn consumers that its diabetes and weight loss drug carries dangerous side effects, including severe gastroparesis (known as stomach paralysis), gastroenteritis, gallbladder disease and other serious health issues. Eli Lilly’s weight loss drug Mounjaro—and Ozempic’s competitor-- is also accused of failure to warn of severe gastrointestinal side effects. The first lawsuit filed in August 2023 follows an investigative report by CNN the previous month, which highlighted a number of Ozempic and Wegovy (another Novo weight loss drug) users suffering from stomach paralysis along with evidence that the diet drug manufacturers knew of the potential risk.

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These drugs have become ‘blockbusters” and have made manufacturers massive profits, mainly due to aggressive off-label marketing and promoting these diabetes drugs as anti-obesity medications. Wegovy is the only drug approved for weight loss. An estimated one in 60 US adults currently has a prescription for Wegovy, Ozempic, or Mounjaro, according to U.K’s  the Daily Mail.  In 2019, about 230,000 prescriptions were filled for Ozempic, Mounjaro, Wegovy or Rybelsus.  (The latter is another Novo drug that uses semaglutide). In 2022, that number rose to more than five million-- an increase of more than 2,000 percent over three years. Doctors told CNN that more cases are being reported as the popularity of the drugs has soared—and more lawsuits are expected as consumers become aware that manufacturers failed to adequately research and warn the medical community about potential side effects.
 

How Ozempic and Mounjaro Work

Ozempic (semaglutide), and Mounjaro (tirzepatide) are both injectable prescription medications that are used to control blood sugar in adults with type 2 diabetes. They both belong to a class of drugs called GLP-1 receptor agonists. Ozempic was approved by the FDA in December 2017 as a once-weekly injection. These drugs work by mimicking GLP-1, a hormone naturally made by the body that regulates appetite and feelings of fullness. It slows the passage of food through the stomach, which helps people feel fuller longer – and helps reduce the number of calories consumed. But if the stomach slows down too much, problems can occur.


Ozempic and Mounjaro Side Effects

The following side effects have been associated with Ozempic:

Gastroparesis (“paralyzed stomach”) occurs when the stomach is slow to empty. It can also result in excessive vomiting and other health issues. The FDA told CNN in July that it had “received reports of gastroparesis with semaglutide and liraglutide, some of which documented the adverse event as not recovered after discontinuation of the respective product at the time of the report.” According to the first lawsuit filed (below), 'Defendants [Lilly and Novo] acknowledge that gastrointestinal events are well known side effects of the GLP-1 class. However, Defendants have downplayed the severity of the gastrointestinal events caused by Ozempic and Mounjaro, never, for example, warning of the risk of gastroparesis (“paralyzed stomach”) or gastroenteritis'.
Mounjaro’s label mentions gastroparesis without warning of the risk; rather, it states that Mounjaro “has not been studied” in patients with gastroparesis or other severe gastrointestinal disease, “and is therefore not recommended in these patients” and it lists gastroparesis among other medical conditions for patients to discuss with their healthcare providers.

Hair loss has been noted by some doctors as a natural result of rapid weight loss, an effect known as telogen effluvium. However, Ozempic may also cause permanent hair loss due to hormonal shifts which can also trigger early onset pattern hair loss in men and women, known as androgenic alopecia. in Dermatology Times, the American Hair Loss Association and The International Alliance of Hair Restoration Surgeons warned against misuse of Ozempic for weight loss.

Thyroid cancer may be linked to Ozempic and Wegovy, warned regulators in the European Union (reported by Health News and other publications). They called for drug manufacturers to turn in additional data and suggested they may take future actions to address the potential risks.

Gallbladder problems were not mentioned on the Ozempic warning label until March 2022, which was then modified to include a specific warning about the potential risk of gallbladder disease associated with the drug. One theory that links Ozempic to gallbladder disease is that these medications not only slow down gastric emptying but also impede the emptying process of the gallbladder.

Ozempic’s prescribing information says the most common adverse events related to the drug are nausea, vomiting, diarrhea, abdominal pain and constipation. Under a section on drug interactions, it says that Ozempic delays gastric emptying, which may impact absorption of oral medications.

Mounjaro’s prescribing information also says nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain are the most common adverse events, and that Mounjaro delays gastric emptying, which may impact medication absorption.

Wegovy and Ozempic (both semaglutide) on their websites list the following side effects:
  • possible thyroid tumors, including cancer.
  • inflammation of your pancreas (pancreatitis)
  • gallbladder problems
  • kidney problems (kidney failure)
  • increased risk of low blood sugar (hypoglycemia)
  • serious allergic reactions. 


Ozempic Lawsuit

The first Ozempic and Mounjaro lawsuit alleging gastroparesis side effects was filed in August 2023 in the U.S. District Court for the District of Louisiana. Jacklyn Bjorklund used Ozempic for more than a year before stopping use and switching to the similar diabetes drug Mounjaro. In her lawsuit, Bjorklund says she has suffered from severe gastrointestinal events, including vomiting, stomach pain, gastrointestinal burning and repeated hospital emergency room visits for stomach issues. As a result of excessive vomiting, some of her teeth fell out and she has been prescribed additional medication to prevent throwing up food hours after eating.

Bjorklund is suing Novo Nordisk and Eli Lilly for failing to warn of the risk of severe gastrointestinal events that could be caused by taking the medications. According to her lawsuit, both manufacturers “knew of the association between the use of GLP-1 receptor agonists and the risk of developing severe gastrointestinal issues, including gastroparesis and gastroenteritis.” 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,” it continues.

Bjorklund’s lawsuit also notes that, over a five-year period, Novo Nordisk spent nearly $900 million on television ads promoting both Ozempic and Wegovy in the U.S., and it also reportedly gifted various doctors a total of $11 million in food and travel expenses as part of their Ozempic promotions.

Over 1 in 10 Americans have reportedly used Ozempic for weight loss, so attorneys anticipate that a significant number of lawsuits will be filed. If you have used any semaglutide medication (Ozempic, Wegovy or Rybelsus) or Mounjaro and you were diagnosed with gastrointestinal issues like gastroparesis gastroenteritis, severe vomiting, nausea, or diarrhea, you may qualify for a lawsuit.  Attorneys say that the main legal issue could be whether the manufacturers knew or should have known about the heightened risks for gastroparesis/stomach paralysis that these drugs posed to users and failed to warn doctors and patients of this risk.
 

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OZEMPIC AND MOUNJARO LEGAL ARTICLES AND INTERVIEWS

Weight Loss Drugmakers Face Stomach Paralysis Lawsuits
Weight Loss Drugmakers Face Stomach Paralysis Lawsuits
January 27, 2024
A drugmaker’s dream is a patient continuing treatment and forever refilling prescriptions--and that spells profit.  Such is the case with the weight loss drugs because discontinuing them leads to regaining lost weight. Ozempic, Mounjaro and Wegovy are star performers, but a drugmaker’s nightmare is the serious side effects that leads to lawsuits, particularly when the manufacturers failed to disclose potential long-term impacts of serious injuries such as gastroparesis. READ MORE

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