Ozempic Stomach Paralysis Lawsuit
The U.S. Food and Drug Administration (FDA) approved the drug Ozempic (semaglutide) on December 5, 2017, for the treatment of type 2 diabetes. Since then, sales of the drug have skyrocketed to the point that it is now used widely throughout the U.S.
Recent reports, however, have suggested that patients taking Ozempic and other drugs like it may be at risk for a serious gastrointestinal disorder called gastroparesis, also known as stomach paralysis. On August 2, 2023, a Louisiana woman filed a lawsuit against the makers of Ozempic, claiming she suffered from serious injuries while taking the drug.
The Ozempic lawyers at Chaffin Luhana are currently examining cases in which patients used Ozempic or other similar drugs and then developed severe intestinal disorders. Call our experienced attorneys to schedule a complimentary consultation at 1-888-480-1123.
What Is Ozempic?
Ozempic (semaglutide) is a once-weekly injectable drug (of 0.5 mg or 1 mg) initially approved in 2017 for the treatment of type 2 diabetes. Designed and manufactured by Novo Nordisk Inc., it belongs to a class of drugs called GLP-1 agonists. These drugs mimic a naturally produced hormone called glucagon-like peptide 1.
GLP-1 is produced in the small intestine. When you eat a meal, the body secretes GLP-1 into the gastrointestinal system. The hormone has many roles in the body, including the following:
- It stimulates insulin secretion, allowing the body’s cells to take up glucose after you eat. This can help keep blood sugar levels steady.
- It helps delay the emptying of the stomach. That means food stays in the stomach longer, causing you to feel satisfied for a longer period.
- By delaying stomach emptying, it slows the release of glucose into the bloodstream. This also helps control blood sugar levels.
- It helps suppress glucagon, another hormone involved in hunger. By doing so, it delays the hunger response.
Studies show that GLP-1 acts on the intestinal wall to slow stomach emptying, activating nerves that slow muscle contractions that would normally push food along.
GLP-1 agonists like Ozempic bind to natural GLP-1 receptors in the body. When they do so, they have similar effects as natural GLP-1. That means they can not only help lower blood sugar levels but may also help encourage weight loss.
FDA Approves Higher Dose of Ozempic
Since the approval of the original Ozempic in 2017, Norvo Nordisk has received several other FDA approvals to expand the marketing and use of the drug.
In 2019, the company received approval to state on the label that Ozempic reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. This allowed the company to market the drug as beneficial against cardiovascular disease in diabetes patients.
In 2022, the company received approval for a higher 2 mg dose of the Ozempic injection. The manufacturer presented as evidence to the FDA results of its clinical trials, which showed that up to 73 percent of people with type 2 diabetes treated with the drug lowered their blood sugar and reached the American Diabetes Association target of less than 7 percent.
The company added that those patients who were still unable to reach their blood sugar target may benefit from the higher dose of the drug, designed for those “who need additional glycemic control.”
As with previous approvals, the manufacturer disclosed important safety information but included no warnings about severe gastrointestinal events like gastroparesis.
It was at this point that the company openly advertised that the drug, though “not a weight loss drug,” may “help people lose some weight.”
Ozempic Side Effects
As with any medication, Ozempic has some known side effects including stomach issues such as diarrhea, constipation, nausea and vomiting, and stomach pain.
Serious side effects listed on the label include pancreatitis (inflammation of the pancreas), changes in vision, low blood sugar, kidney failure, and allergic reactions. In 2022, Novo Nordisk added a warning about gallbladder issues to the official disclosers.
Ozempic and Gallbladder Disease
On August 29, 2022, the scientific journal JAMA Internal Medicine published a research letter concerning the risks of Ozempic and other GLP-1 medications. The authors examined data from the FDA’s Adverse Event Reporting System (FAERS) and found that those taking Ozempic and other similar drugs had a significantly higher rate of gallbladder health issues, particularly acute gallbladder disease (acute cholecystitis).
This occurs when the gallbladder becomes suddenly inflamed because gallstones block the tube leading out of the gallbladder. It requires medical treatment and often, surgery to remove the gallbladder. The risk was higher in patients who used the higher dose of the drug, who took it for longer durations, and who used it for weight loss.
Two previous studies showed similar results. In 2017 and 2020, researchers found that patients treated with GLP-1 agonists had a significantly increased risk of gallstones.
Due to these studies and increased patient reports of gallbladder problems, Novo Nordisk modified the Ozempic label in 2022 to include a specific warning about the potential risk of gallbladder disease associated with the drug. Before this, there was no such warning about gallbladder disease.
What Is Gastroparesis?
As early as 2020, there were studies noting that GLP-1 agonists could exacerbate existing symptoms of diabetic gastroparesis. Later, other evidence suggested that the drug itself seemed to be bringing on the problem.
Gastroparesis is a condition that affects the stomach nerves and muscles. Usually, these work together to propel food through the digestive tract. Gastroparesis—also called paralysis of the stomach—makes the stomach muscle contractions weaker and slower than usual. Sometimes it stops the contractions altogether.
This leads to food sitting too long in the stomach, which causes symptoms like vomiting, nausea, abdominal bloating, abdominal pain, a feeling of fullness after eating only a few bites, acid reflux, lack of appetite, and ultimately, weight loss.
Doctors don’t know what causes gastroparesis, but they know that it can be a complication of uncontrolled diabetes. About one-third of cases are diagnosed as diabetes-related, according to the Cleveland Clinic.
Ozempic and Gastroparesis
In 2020, researchers published a study that included some information about GLP-1 agonists and gastroparesis. They noted that this class of drugs can “exacerbate the symptoms of diabetic gastroparesis,” adding that “GLP-1 receptor agonist therapy is not recommended for people who experience symptoms of gastroparesis.” Yet the manufacturer made no change in its prescribing recommendations to doctors.
In 2021, doctors published a case report on two patients who had been taking weekly injections of GLP-1 agonist medications before the onset of gastroparesis symptoms. In the first case, the woman had started injections only a month before her symptoms started. The case report authors concluded that “thorough history taking revealed the cause to be medication induced.” In both cases, when the patients discontinued the medications, their symptoms improved.
In July 2023, the news site CNN reported that patients taking GLP-1 agonists like Ozempic and Wegovy (both include the same medication, semaglutide) had suffered from gastroparesis after starting the medication. The report included a statement from the FDA indicating 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.”
The FDA did indicate at the time that it had been unable to determine whether the medications directly caused the injuries.
Ozempic May Drastically Slow Stomach Emptying
It’s one thing to say Ozempic slows stomach emptying. That sounds good if you’re trying to lose weight. But studies indicate that GLP-1 drugs like Ozempic may be slowing stomach emptying much more drastically than patients may believe.
In a 2017 study on liraglutide, for instance—a long-acting GLP-1 agonist that is approved for treating obesity—researchers recruited 40 adults and split them into two groups. They gave one group liraglutide and another a placebo for 16 weeks. Then they measured the time taken for a meal to empty from the stomach at 5 weeks and again at 16 weeks.
The results showed that people taking liraglutide, on average, took 70 minutes for half the food to leave the stomach, compared to 4 minutes in those taking a placebo. In some participants, it took as long as 151 minutes for half the food to leave the stomach.
Study author Michael Camilleri said, “It is conceivable that some patients may have borderline slow gastric emptying and starting one of the GLP-1 agonists may precipitate a full-blown gastroparesis.”
On June 29, 2023, the American Society of Anesthesiologists warned that patients taking Ozempic should stop the medication at least a week before elective surgery. Ozempic and other GLP-1 agonists, they wrote, delayed stomach emptying and increase the risk of a patient regurgitating and aspirating food into the airways and lungs during deep sedation. This could damage fragile lung tissue and result in the patient having to be on a ventilator.
Ozempic Manufacturers Play Up Weight-Loss Angle
Though Ozempic is FDA-approved only for the treatment of type 2 diabetes, the manufacturers have played up the weight-loss angle in their advertisements. This has led to more patients requesting the drug for weight loss purposes alone. Doctors are allowed to prescribe medications like this “off-label,” meaning for indications not specifically outlined by the FDA.
As early as 2018, Novo Nordisk launched their first television ad for Ozempic in which they noted that “adults lost on average up to 12 pounds” when taking the drug. Meanwhile, they spent hundreds of thousands of dollars on additional television ads for Ozempic and other semaglutide drugs including Webovy and Rybelsus.
In June 2023, The Washington Post published an article noting that GLP-1 drugs “are fueling a frenzy among patients and a gold-rush within the pharmaceutical industry” because of their links with weight loss: “There may be no buzzier medication on the market than GLPs. They are being popularized by celebrities, going viral on social media…They are also generating windfalls for pharmaceutical firms big and small…”
The author, Daniel Gilbert, indicated that insurance companies were cracking down on doctors prescribing drugs like Ozempic off-label for weight loss in patients without type 2 diabetes. Doctors often do so to help their overweight patients since Ozempic costs less than GLP-1 drugs that are specifically approved to treat weight loss, like Wegovy.
High demand for these drugs has pushed some GLP-1 agonist medications—including Ozempic—onto the FDA’s Drug Shortages list. As of May 2023, Ozempic was still on that list. According to the American Society of Health-System Pharmacists (ASHP), Ozempic is on the shortage list “due to increased demand.”
Ozempic Lawsuit Filed
On August 2, 2023, a Louisiana woman filed a lawsuit against Ozempic and Mounjaro manufacturers, claiming that the diabetes drugs caused her to suffer from gastroparesis. Mounjaro is also a GLP-1 agonist and is manufactured by Eli Lilly and Company.
The plaintiff stated that she used Ozempic for more than one year, stropping in July 2023. At that point, she started using Mounjaro. She claims that both drugs caused her to suffer severe gastrointestinal events that resulted in severe vomiting, stomach pain, and being hospitalized for stomach issues on several occasions.
She notes that the prescribing information for these drugs does not disclose the risk of severe gastrointestinal events, including gastroparesis. She brings counts of inadequate warning and breach of warranties.
As awareness increases concerning a potential link between Ozempic and other GLP-1 agonists and the increased risk of several stomach problems, more plaintiffs will likely file lawsuits like this one.
Potential Injuries Related to Ozempic
Using Ozempic, particularly at higher doses or for long periods, may increase the risk of:
- Gallstones
- Acute gallbladder disease (cholecystitis)
- Pancreatitis
- Thyroid tumors or thyroid cancer
- Diabetic retinopathy
- Hypoglycemia (low blood sugar)
- Gastroparesis (stomach paralysis)
- Vision loss
Ozempic Lawsuits
Plaintiffs who have used Ozempic (semaglutide) and then suffered from severe gastrointestinal issues like gastroparesis may be entitled to file a personal injury lawsuit.
If you or a loved one used any form of Ozempic and then suffered from these injuries, call our experienced attorneys to schedule a complimentary consultation at 1-888-480-1123.
Frequently Asked Questions
Can Ozempic Cause Intestinal Issues?
Yes. Because Ozempic slows the speed of stomach emptying, it can cause minor issues such as diarrhea, constipation, nausea, and stomach pain. In some cases, there have been links between Ozempic and more serious intestinal issues like gastroparesis.
Should I Stop Taking Ozempic?
If you’re noticing digestive symptoms that seem more serious than usual—or if you’ve experienced slowed stomach emptying before taking Ozempic—talk to your doctor about a possible alternative. Do not stop taking your medication without talking to your doctor first.
Am I Eligible for an Ozempic Lawsuit?
If you used Ozempic and subsequently developed a serious gastrointestinal disorder that caused you to go to the hospital, you may be eligible to file an Ozempic lawsuit. Talk to an Ozempic attorney about your options.
Is Ozempic Dangerous for Non-Diabetics?
If you don’t have diabetes and you take Ozempic, you could be at risk for hypoglycemia (low blood sugar). Watch for symptoms like confusion, rapid heartbeat, and sweating. Because Ozempic delays stomach emptying, it could also cause dangerous intestinal problems. Talk to your doctor about any digestive issues you may have before taking Ozempic.
Is Ozempic Safe to Take for Life?
We don’t have enough studies yet to determine the safety of Ozempic when taken for life. If you have type 2 diabetes, your doctor can discuss with you the risks and benefits to help you make a choice.
If you don’t have diabetes but want to try Ozempic for weight loss, understand that the medication works only as long as you take it. Should you lose weight on Ozempic and then stop the medication, you are likely to regain that weight. This may encourage you to take the medication long-term. Consider the risks and benefits carefully.