The Risk of Severe Stomach Problems Associated with Diabetes Drugs Ozempic and Mounjaro
Lawsuit Claims Drugmakers Failed to Warn Patients
The drugmakers Novo Nordisk and Eli Lilly failed to adequately warn patients about the possible risk of severe stomach problems associated with their blockbuster drugs Ozempic and Mounjaro, according to a lawsuit filed Wednesday.
First Lawsuit Alleging Gastrointestinal Injuries
The 26-page lawsuit, filed on behalf of a Louisiana woman who says she was “severely injured” after taking the two diabetes drugs, is the first to allege that they can cause gastrointestinal injuries.
About Ozempic and Mounjaro
Ozempic and Mounjaro are both part of a new class of medicines known as GLP-1 agonists. They help people with Type 2 diabetes manage their blood sugar levels and are also prescribed off-label for weight loss.
- GLP-1 medications slow down food movement in the stomach, making a person feel fuller longer.
- Potential side effects of these drugs include abdominal pain, nausea, and vomiting.
Allegations and Health Problems
Jaclyn Bjorklund, 44, of Louisiana, is accusing the drugmakers of failing to disclose other health problems allegedly caused by the medications, including severe gastroparesis and persistent vomiting.
- Gastroparesis is a condition that slows or stops the movement of food out of the stomach and into the small intestines.
- It can be caused by underlying medical issues, and one of the more common causes is diabetes.
- While not mentioned in the prescribing information, delays gastric emptying is listed on both drugs’ labels.
Response from FDA and Drugmakers
The Food and Drug Administration declined to comment on the lawsuit, stating that it is 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. Novo Nordisk, on the other hand, said they were not aware of the lawsuit but acknowledged that gastroparesis is a known risk for people with diabetes.
Potential Compensation and Future Cases
About 400 people have come forward claiming to have gastrointestinal injuries caused by the diabetes medications, and more cases are expected to follow.
Bjorklund, the plaintiff, is seeking significant compensation from the drugmakers, although the specific amount was not disclosed.
Dr. Shauna Levy, a specialist in obesity medicine, expressed surprise at the lawsuit. She mentioned that while the medications could cause gastroparesis, the problem could also be caused by other undiagnosed illnesses or by the patient’s diabetes.
Continued Monitoring by FDA
The FDA will continue to monitor for any potential adverse events from the medications and take appropriate actions based on a thorough review of evidence.
About the Author
Berkeley Lovelace Jr. is a health and medical reporter for NBC News, specializing in the Food and Drug Administration and healthcare topics.