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Lawsuit Claims Ozempic and Mounjaro Failed to Warn of Vomiting Risks

Ozempic, the brand name for semaglutide, has been the talk of the town throughout 2023 and remains a large topic for discussion for being widely used as a weight loss drug. It was originally designed to treat type 2 diabetes mellitus. However, people experiencing an array of adverse side effects from using the drug are now filing lawsuits against the manufacturer, Novo Nordisk, alleging that they have failed to disclose other health problems allegedly caused by the medications, including severe gastroparesis, ileus, intestinal blockage as well as “persistent” vomiting. The claimants are seeking compensation for the Ozempic-related injuries. 

The first Ozempic lawsuit was filed on Aug 2, 2023, by a Louisiana woman who was prescribed Ozempic before switching to Mounjaro pen, has sued both drug manufacturers, alleging that they failed to adequately warn the patients and their doctors about the association of their drug with gastrointestinal issues. In the early weeks of February,at least 55 lawsuits were combined into a multidistrict litigation by a federal panel.

As of April 2024, there are 74 lawsuits of personal injury for ileus, gastroparesis and intestinal obstruction or blockage in the official Ozempic lawsuit MDL 3094 in the Eastern District of Pennsylvania before Judge Gene E.K. Pratter.

Overview of the Legal Claims

In the summer of 2023, Novo Nordisk and Eli Lilly and Co., the manufacturers of blockbuster GLP-1 receptor agonist drugs Ozempic and Mounjaro, respectively, were sued by a Louisiana woman alleging that they had failed to warn the physicians and their patients about the potential side effects of using these medications. The plaintiff in the 26-page lawsuit is Jaclyn Bjorklund, a 44-year-old woman from Louisiana diagnosed with type 2 diabetes mellitus who was prescribed ozempic before she switched to Mounjaro. She has sued both companies, claiming both drug manufacturers failed to inform her about the risks of severe gastroparesis, ileus, and intestinal blockage, which caused her to visit the emergency room several times and even lose her teeth due to vomiting so violently. 

Allegations in the Lawsuit

The lawsuit filed against the drug companies alleges that their drugs can cause gastroparesis or delayed gastric emptying. Gastroparesis is a dangerous condition in which the nerves and muscles of the stomach wall are severely weakened, which makes it difficult for the stomach to transfer food into the small intestine. Gastroparesis can result in intestinal obstruction or blockages, which can further cause diarrhea and vomiting/nausea. 

It is important to note that gastroparesis cannot be cured and can only be managed through medical interventions. The plaintiffs in the lawsuit have alleged that Novo Nordisk has downplayed or concealed the risks, and there are other potential side effects of using the medications, such as possible connection to suicide ideation and association with gallbladder disease. It is being said that these side effects can further lead to legal actions against the companies.  

Gastroparesis

Gastroparesis is a chronic condition that inhibits the transfer of food out of the stomach and into the small intestines. Many medical issues could lead to gastroparesis, the most common one being diabetes. Viral infections, autoimmune disorders, surgeries that injure the nerves, and certain medications such as antidepressants and narcotics can result in the condition. 

While the term “gastroparesis” is not mentioned anywhere in the prescribing information for both medications, Mounjaro or Ozempic, “delayed gastric emptying” is listed on both drugs’ prescription labels, as it can affect how your body absorbs the medication. Common symptoms of gastroparesis may include nausea/vomiting, weight loss and a feeling of fullness.

Do Weight-loss Drugs Cause it?

More than just being a mere side effect, gastroparesis is the actual reason why the patients lose weight and keep the lost weight off for a long time on drugs like Ozempic. It increases your feelings of fullness after eating a meal. While taking GLP-agonist receptor agonists, if you continue to eat large portions and high-fat, high-fiber food items that take longer to digest may also exacerbate the symptoms. 

Ileus

Ileus refers to the inhibition of gastrointestinal propulsion that can sometimes result in partial or complete bowel obstructions. Symptoms of ileus may include nausea/vomiting, bloating, cramping and constipation. With restrictions on fluids and food, ileus usually goes away on its own after 1-3 days. However, obstructions in the bowel can be fatal if they cause uncontrollable vomiting in the patients. After patients reported 33 cases of ileus, including two deaths, the Food and Drug Administration added a warning about ileus to Ozempic’s label. 

Can it be life-threatening?

If you have a blockage in your intestines that is left untreated and nothing can pass through your small or large intestines, that can be potentially fatal, leading to potential infection or tissue death. Depending on how your condition is treated, there can be long-term effects, too. If a patient plans to undergo surgery to remove the blocked part of their intestine, it can lead to scar tissue, a risk factor for developing further obstructions. If a large segment of the intestine is removed, it can also lead to difficulty in the absorption of nutrients from food.

Drugmakers Claim that ‘These Risks Were Communicated’ 

In response to the lawsuits, Novo Nordisk has released public statements emphasizing that their products are safe to use and the patient’s safety is their top priority. They stated that they continuously monitor the safety profile of their medicines. Eli Lilly also issued an open letter to the public in which they said that its drugs Mounjaro and Zepbound are not recommended to be used for cosmetic weight loss and that they will vigorously defend against the lawsuits, noting that their FDA-approved labels clearly warn of gastrointestinal adverse reactions. Both Eli Lilly and Novo Nordisk say that they have provided sufficient warnings about these side effects, which are listed on the drugs’ labels. 

The lawsuits are part of a broader discussion around the new class of medications known as GLP-1 agonists, which includes Ozempic and Mounjaro. These drugs work by slowing the transfer of food particles through the stomach, which can lead to an increase in feelings of fullness for longer but can also cause gastrointestinal issues like nausea/vomiting and abdominal pain. These drugs were originally designed to help patients with diabetes type 2 manage their blood glucose levels. They are now popularly being prescribed off-label for weight loss. The lawsuit is ongoing, with some cases being combined into multidistrict litigation. The outcome of the hearing will provide further clarity on drug manufacturers’ responsibilities to warn about risks. 

How to Manage the Side Effects of Ozempic and Mounjaro?

If you are experiencing side effects while using GLP-1 medications or if you are taking Ozempic, Wegovy or Mounjaro, you can contact your healthcare provider or physician. After reading your symptoms carefully, they can order tests to determine if you are facing issues due to the medication. The most common side effects of ozempic, according to Novo Nordisk, may include nausea/vomiting, diarrhea, constipation and abdominal pain. Some rare but adverse side effects of the medication are pancreatitis, hypoglycemia, changes in vision, severe allergic reactions, and kidney and gallbladder problems. Novo Nordisk’s Mounjaro has a similar list of potential side effects, but its list of adverse side effects also includes severe gut problems. It is crucial to take the medication only through a prescription by a licensed physician or healthcare professional. 

Takeaway 

In the year 2023, a woman from Louisiana filed the first Ozempic lawsuit against the drug manufacturers of popular antidiabetic medications Ozempic and Mounjaro after experiencing severe gastrointestinal events, including gastroparesis, ileus and intestinal blockage, which caused her to visit the emergency room several times and even lost her teeth due to vomiting so violently.
Those individuals planning to buy Mounjaro online Canada or any other GLP-1 or similar medications for diabetes management and weight loss should consult their doctor regarding any query or concern regarding the potential side effects of the drug and report any unusual side effects right away.

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