"Legal Battle Unfolds as Woman Sues Ozempic and Mounjaro Manufacturers, Alleging Severe Gastrointestinal Side Effects"

LOS ANGELES, CALIFORNIA - APRIL 17: This photo illustration depicts boxes of the diabetes drug Ozempic resting on a pharmacy counter on April 17, 2023, in Los Angeles, California. Ozempic was initially 1¹¹1111¹¹¹¹FDA-approved to treat individuals with 1 2 diabetes who face severe health war q1risks without medication. In recent months, there has been a significant increase in demand for Ozempic, or semaglutide, due to its weight loss benefits, resulting in shortages. Some doctors prescribe Ozempic off-label to address obesity. (Photo illustration by Mario Tama/Getty Images.

Cnn_On Wednesday, a lawsuit was filed by a Louisiana woman, asserting that she has endured severe injuries as a result of using Ozempic and Mounjaro, both of which were prescribed to her by her doctor. These two injectable medications, initially designed for managing diabetes, hakmllv weve become increasingly popular for their purported weight loss effects. The plaintiff alleges that her use of these medications for weight loss purposes led to the development of severe health issues.

Jaclyn Bjorklund's attorneys assert that the 44-year-old woman had been utilizing Ozempic for over a year until approximately July 2023. Subsequently, she switched to using Mounjaro. Now, she is taking legal action against the manufacturers of both drugs, Novo Nordisk and Eli Lilly, alleging that they failed to provide sufficient warning regarding the potential risk of severe gastrointestinal events associated with the use of these medications. The lawsuit centers around the claim that the companies did not adequately inform consumers about the potential side effects, which led to the unfortunate health issues experienced by Jaclyn Bjorklund.

The lawsuit alleges that due to her usage of Defendants' Ozempic and Mounjaro, the Plaintiff suffered from severe gastrointestinal events, resulting in severe and permanent personal injuries, pain, suffering, and emotional distress, as well as incurring medical expenses.

Bjorklund's health has been significantly impacted by a range of distressing symptoms, including severe vomiting, stomach pain, and gastrointestinal burning. These issues have been so severe that she has been hospitalized on multiple occasions, even requiring visits to the emergency room. Additionally, her persistent vomiting has led to the unfortunate loss of her teeth, and she has had to rely on additional medications to manage her excessive vomiting. To make matters worse, she has been experiencing the unsettling phenomenon of throwing up whole food hours after eating. The severity and persistence of these symptoms have undoubtedly taken a toll on her physical and emotional well-being.

According to the lawsuit, Novo Nordisk and Eli Lilly are accused of having knowledge about the link between the use of GLP-1 receptor agonists and the potential for severe gastrointestinal problems such as gastroparesis and gastroenteritis. The claim suggests that these companies were aware of this association but failed to adequately warn the public or take necessary precautions to prevent such adverse effects. The lawsuit seeks to hold them accountable for allegedly not disclosing the risks associated with their products, potentially putting patients at risk of developing these serious health issues.

The statement alleges that the responsible party failed to disclose vital information they possessed about the connection between using GLP-1 receptor agonists and the heightened risk of severe gastrointestinal issues such as gastroparesis and gastroenteritis. This omission resulted in the medication's warnings being considered inadequate. The implication is that if the information had been properly disclosed, patients and healthcare professionals would have been better informed about the potential risks associated with the medication.

The prescribing information for Ozempic and Mounjaro includes vomiting and abdominal pain as potential adverse events. The lawsuit does not specify whether Bjorklund received a diagnosis of gastroparesis, which is stomach paralysis.

The lawsuit seeks compensatory and punitive damages to account for the pain and suffering Bjorklund experienced in the past and might endure in the future. These damages would also cover her health care costs, medical monitoring, attorney's fees, and court expenses. The case aims to address the harm caused and hold the responsible party accountable for their actions.

Novo's Ozempic and a similar drug called Wegovy both utilize the same medication, semaglutide. On the other hand, Eli Lilly's Mounjaro uses tirzepatide. These drugs, along with others in this family, such as liraglutide, function by mimicking a hormone naturally produced by the body, GLP-1. This hormone slows down the passage of food through the stomach, helping people feel fuller for a longer duration.

Apart from the new lawsuit, CNN has reported on warnings issued by patients and doctors regarding potential side effects like gastroparesis after using Wegovy and Ozempic for weight loss or diabetes treatment. These medications, while effective in helping people manage their weight or blood sugar levels, have raised concerns due to adverse reactions experienced by some individuals. These reports underscore the importance of close monitoring and consultation with healthcare professionals when using such drugs.

Gastroparesis, a condition characterized by the slowing of stomach emptying, can lead to nausea and vomiting in certain patients. It has various causes, and diabetes is among the reasons why many individuals take medications. Women are known to be at a higher risk of developing this condition. Proper medical supervision and awareness of these risks are crucial for those using drugs like Ozempic, Wegovy, or other medications for diabetes or weight management.

Doctors informed CNN that as the popularity of drugs like Ozempic and Wegovy has increased, more cases of side effects, including gastroparesis, are being reported. Before the lawsuit, the US Food and Drug Administration (FDA) acknowledged that it had received reports of gastroparesis associated with semaglutide and liraglutide. Some of these reports documented adverse events that had not resolved even after discontinuing the respective medication at the time of reporting. The growing number of cases underscores the need for ongoing vigilance and research into the safety and potential side effects of these drugs.

According to Ozempic's prescribing information, the most frequently reported adverse events related to the drug include nausea, vomiting, diarrhea, abdominal pain, and constipation. In the section concerning drug interactions, it states that Ozempic can delay gastric emptying, potentially affecting the absorption of oral medications. This highlights the importance of considering potential interactions and consulting healthcare professionals when taking medications in conjunction with Ozempic or similar drugs in this class. Being aware of these effects can help ensure safe and effective treatment for patients.

As stated in Mounjaro's prescribing information, the most frequently observed adverse events associated with the medication are nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain. Additionally, Mounjaro, like Ozempic and other GLP-1 receptor agonists, is known to delay gastric emptying, which could potentially influence the absorption of other oral medications taken simultaneously.

This information emphasizes the importance of understanding the potential side effects of Mounjaro and the necessity of considering its interactions with other drugs. Patients and healthcare professionals should be aware of these effects to make informed decisions about treatment and minimize any potential risks. Regular monitoring and communication with healthcare providers are crucial to ensure safe and effective use of Mounjaro or similar medications in managing weight or diabetes.

In their response to CNN regarding concerns about stomach paralysis prior to the lawsuit, Novo Nordisk, the manufacturer of Ozempic and Wegovy, stated, "Gastrointestinal (GI) events are widely recognized as side effects of the GLP-1 class. For semaglutide, the majority of GI side effects are typically mild to moderate in severity and of short duration. GLP-1s are known to induce a delay in gastric emptying, as stated in the label of each of our GLP-1 RA medications. Symptoms of delayed gastric emptying, such as nausea and vomiting, are listed as potential side effects."

In their response to the recent lawsuit, a Novo Nordisk spokesperson informed The Hill that "Ensuring patient safety is our top priority at Novo Nordisk. We constantly monitor the safety profile of our products and work closely with authorities to safeguard patient well-being. This includes providing comprehensive information about gastrointestinal side effects in the product label."

In a statement obtained by The Hill, a spokesperson for Eli Lilly, the maker of Mounjaro, emphasized that patient safety is the company's "top priority." The spokesperson stated that they actively monitor, evaluate, and report safety information for all their medicines. CNN has contacted both Novo Nordisk and Eli Lilly for their response to the lawsuit.