Pharmaceutical giants Novo Nordisk and Eli Lilly are being sued for failing to adequately warn patients about the possible risk of severe stomach problems linked to their blockbuster diabetes drugs Ozempic and Mounjaro, according to a 26-page lawsuit filed last week in the US.
Both drugs are part of a new class of medicines known as GLP-1 agonists and help people with type 2 diabetes manage their blood sugar levels, but are also prescribed off-label for weight loss.
In the court papers, a woman says she was “severely injured” after taking the two drugs: she is also the first to allege they can cause gastrointestinal injuries, reports NBC.
GLP-1 medications work, in part, by slowing the speed at which food moves through the stomach, which can lead to someone feeling fuller for longer. They can also, however, cause gastrointestinal issues, including abdominal pain, nausea and vomiting, which have been well documented in clinical trials and are listed as potential side effects on the drugs’ labels.
Jaclyn Bjorklund (44) is accusing the drugmakers of failing to disclose other health problems allegedly caused by the medications, including severe gastroparesis, also known as stomach paralysis, and “persistent” vomiting, said attorney Paul Pennock.
Gastroparesis is a condition that slows or stops the movement of food out of the stomach and into the small intestines. It’s sometimes referred to as “delayed gastric emptying” and can be caused by underlying medical issues.
One of the more common causes of gastroparesis is diabetes, according to the American College of Gastroenterology. It can also result from infections or certain medications, including narcotics and antidepressants.
While “gastroparesis” is not mentioned in the prescribing information for Ozempic or Mounjaro, “delays gastric emptying” is listed on both drugs’ labels, because it can affect how other medications are absorbed by the body.
The US Food and Drug Administration declined to comment but a spokesperson said it was unclear whether the GLP-1 medications contribute to the occurrence of gastroparesis.
A spokesperson for Eli Lilly did not immediately respond to a request for comment on the lawsuit, while a Novo Nordisk spokesperson said gastroparesis is a known risk for people with diabetes.
About 400 people have come forward claiming to have gastrointestinal injuries caused by the diabetes medications, said Pennock, adding that he ultimately expects to see “thousands of such cases”.
Bjorklund was diagnosed with type 2 diabetes in 2017 and had been prescribed Ozempic before later switching to Mounjaro, and is claiming that she was “severely injured” by the medications and had to go to the emergency room multiple times due to stomach problems. The lawsuit said she vomited so violently that she lost teeth.
While she hasn’t yet been diagnosed with gastroparesis, Pennock said her symptoms are “indicative of” the condition and dismissed the suggestion that the condition was caused by her diabetes.
Dr Shauna Levy, a specialist in obesity medicine and the medical director of the Tulane Bariatric Centre in New Orleans, said she was surprised by the lawsuit.
While the medications could cause gastroparesis, Levy, who is not involved with Bjorklund’s treatment, said that the problem could also be caused by another undiagnosed illness or by the patient’s diabetes, and then exacerbated by the medications.
“As a provider, I’m not worried about this being a common problem,” she said.
NBC News article – Makers of Ozempic and Mounjaro sued over ‘stomach paralysis’ claims (Open access)
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