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A Louisiana woman who sued the manufacturers of popular diabetes and weight loss drugs Ozempic and Mounjaro is alleging the drugmakers failed to warn the public about the risk of severe gastrointestinal problems.
Jaclyn Bjorklund, 44, who on Wednesday filed the 26-page lawsuit in U.S. District Court for the Western District of Louisiana Lake Charles Division, claims she was “severely injured” after taking the two medications.
According to the complaint, Novo Nordisk and Eli Lilly, the manufacturers of Ozempic and Mounjaro, respectively, “downplayed the severity of the gastrointestinal events,” such as gastroparesis and gastroenteritis, caused by the drugs.
Gastroparesis, a disorder that “slows or stops the movement of food from your stomach to your small intestine, even though there is no blockage in the stomach or intestines” is frequently caused by diabetes. Narcotics and antidepressants also are linked to gastroparesis.
Ozempic (semaglutide) and Mounjaro (tirzepatide) are injectable diabetes medications, approved by the U.S. Food and Drug Administration (FDA), CBS News reported. Mounjaro was approved in May 2022. Ozempic was first approved in December 2017, and approved at a higher dose in March 2022.
According to NBC News, Bjorklund is the first person to come forward alleging that the drugs in question cause gastrointestinal injuries.
The two drugs are part of a new category of medicines known as glucagon-like peptide-1, or GLP-1, receptor agonists. They are intended to help people with Type 2 diabetes manage their blood sugar levels. However, the medications are also commonly prescribed off-label for weight loss.
According to CBS News, “These drugs were originally developed to treat patients with Type 2 diabetes as they produce insulin and lower blood sugar. They also release a hormone that slows down digestion and keeps food in a patient’s stomach longer.”
However, their long-term impact is unknown.
According to CNN, “The lawsuit is seeking compensatory and punitive damages for past and future pain and suffering Bjorklund will have including health care costs and medical monitoring as well as her attorney’s fees and court costs.”
Attorneys Paul Pennock and Jonathan Sedgh, of Orlando-based Morgan & Morgan, said during a press conference, that the basis of the lawsuit is “a failure to warn,” CBS News reported. Pennock told the press:
“It is our opinion that these drugs are causing these problems. We think that the evidence is sufficient for us to be able to prove it or we would not have filed the case, and we intend to file many more in the coming days and weeks.
“[Bjorklund’s] problems have been so severe that she’s been to the emergency room multiple times, including last weekend. She’s actually even thrown up so violently that she’s lost teeth.”
This is the first lawsuit alleging the two drugs caused gastrointestinal injuries, however, lawyers representing Bjorklund said hundreds more similar lawsuits are ready to be filed by victims across the U.S.
Ozempic recently was linked to a range of other health issues, including kidney disorders and causing suicidal thoughts.
Plaintiff suffered from ‘severe gastrointestinal events’
The lawsuit states that Bjorklund, who was diagnosed with Type 2 diabetes in 2017, was prescribed Ozempic and took the drug for more than a year before switching to Mounjaro.
During this period, she experienced “severe gastrointestinal events,” including severe vomiting — which also led to the loss of teeth, gastrointestinal burning and stomach pain. As a result, the complaint states, Bjorklund “sustained severe and permanent personal injuries, pain, suffering, and emotional distress, and incurred medical expenses.”
The lawsuit also alleges the two companies “knew of the association between the use of GLP-1 receptor agonists and the risk of developing severe gastrointestinal issues, including gastroparesis and gastroenteritis.”
The companies’ “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,” the lawsuit adds.
According to The Hill, “While the labels for both medications note that they delay gastric emptying and can cause a variety of stomach problems — including nausea, vomiting, diarrhea, abdominal pain and constipation — they do not explicitly warn of gastroparesis as a risk.”
CNN reported that “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.”
Similarly, “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.”
However, due to the lack of an explicit warning regarding gastroparesis, the lawsuit alleges that Bjorklund “was and still is caused to suffer from severe gastrointestinal issues, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain, and mental anguish.”
In statements, both companies defended their products. Novo Nordisk claimed that gastrointestinal events are “well-known side effects of the GLP-1 class,” according to CBS News. The company added:
“For semaglutide, the majority of GI side effects are mild to moderate in severity and of short duration. GLP-1’s are known to cause a delay in gastric emptying, as noted in the label of each of our GLP-1 RA medications. Symptoms of delayed gastric emptying, nausea and vomiting are listed as side effects.”
And, as reported by The Hill:
“Patient safety is of utmost importance to Novo Nordisk. … We are continuously monitoring the safety profile of our products and collaborate closely with authorities to ensure patient safety, including adequate information on gastrointestinal side effects in the label.”
Eli Lilly said patient safety is its “top priority,” according to CBS News, and the company is “actively engage[d] in monitoring, evaluating and reporting safety information for all our medicines.”
NBC News cited FDA spokesperson Chanapa Tantibanchachai, who said it’s “unclear” whether GLP-1 medications are connected to occurrences of gastroparesis.
A separate FDA statement cited by CNN states the agency has “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.”
‘This medicine made my life hell’
However, lawyers for Bjorklund say that many more patients are ready to come forward with lawsuits of their own.
According to CBS News, Pennock’s firm “is investigating 400 other inquiries from clients across 45 states,” while according to The Hill, Pennock ultimately expects to see “thousands of such cases.”
Several patients also spoke to media outlets regarding their injuries.
Brea Hand told CBS News, “The stomach pain was just unbearable and I couldn’t keep anything down. I would drink something and within minutes, like five, 10 minutes later, I would be throwing up.”
Hand visited the hospital six times while taking Ozempic and was admitted to an intensive care unit. She is not involved in the lawsuit.
A July 25, CNN featured the stories of other patients, including Louisiana resident Joanie Knight, 37, who said “I wish I never touched it. I wish I’d never heard of it in my life,” referring to Ozempic. “This medicine made my life hell. So much hell.”
And Emily Wright, a 38-year-old teacher from Toronto, began taking Ozempic in 2018. Today though, despite not having taken the medication “for a year,” she said, “I’m still not back to my normal.” She told CNN she is now vomiting so frequently that she was obliged to take a leave of absence from her job.
In recent months, several reports have indicated that Ozempic in particular is linked to a range of other health problems.
Last month, health regulators in Iceland, followed by the European Medicines Agency, began investigating reports that Ozempic and other popular weight-loss drugs are linked to the inducement of suicidal thoughts.
In June, a report by Dr. Joseph Mercola referenced studies based on data from Eudravigilance, Europe’s system for analyzing adverse reactions to medications. The data showed a link between Ozempic and a high prevalence of gastrointestinal disorders. This confirmed findings from a separate study conducted in 2018.
And in April, the FDA warned that Ozempic should be discontinued at least two months prior to pregnancy because it takes that long for the body to eliminate the drug.
However, those warnings are buried, and long-term testing won’t be completed for years. The drug was not studied in pregnant women during clinical trials.