In a recent development that has sent shockwaves through the pharmaceutical sector, two prominent drug manufacturers, Novo Nordisk and Eli Lilly, are now embroiled in a lawsuit. The legal action stems from allegations that the companies did not provide adequate warnings to patients about the potential for severe gastrointestinal complications linked to their flagship diabetes drugs, Ozempic and Mounjaro.
This lawsuit, initiated by a Louisiana woman who alleges severe injury after using these drugs, is the first of its kind to suggest that these medications could lead to serious gastrointestinal harm. A report published by NBC mentions, Ozempic and Mounjaro are part of an innovative category of medicines known as GLP-1 agonists. These drugs are primarily prescribed to individuals with Type 2 diabetes to help them control their blood sugar levels. Interestingly, they are also used off-label for weight loss purposes.
The mechanism of action of these drugs involves decelerating the rate at which food travels through the stomach, thereby prolonging the sensation of satiety. However, this slowed gastric motility can also lead to gastrointestinal disturbances, such as abdominal discomfort, nausea, and vomiting. These side effects have been extensively documented in clinical trials and are explicitly mentioned on the drugs’ labels.Â
The plaintiff in the case, Jaclyn Bjorklund, has leveled accusations against the pharmaceutical giants, claiming they did not disclose other health issues purportedly induced by the medications. These include severe gastroparesis, colloquially known as stomach paralysis, and continuous vomiting. Gastroparesis is a medical condition characterized by delayed or halted movement of food from the stomach to the small intestines. This condition can be triggered by a variety of underlying health issues, including diabetes, infections, or the use of certain medications.Â
Interestingly, while the term “gastroparesis” does not appear in the prescribing information for Ozempic or Mounjaro, both drugs’ labels do mention “delays in gastric emptying.” This is because such delays can influence how other medications are absorbed by the body. The Food and Drug Administration (FDA), when asked to comment on the lawsuit, declined. It remains uncertain whether GLP-1 medications contribute to the development of gastroparesis.Â
Bjorklund, who received a Type 2 diabetes diagnosis in 2017, was initially prescribed Ozempic before transitioning to Mounjaro. She alleges that these medications caused her severe harm, necessitating multiple emergency room visits due to stomach issues. Her lawsuit claims that the severity of her vomiting led to tooth loss. Bjorklund is now seeking substantial compensation from the drug manufacturers.Â
The lawsuit has elicited surprise from some quarters of the medical community. Dr. Shauna Levy, a specialist in obesity medicine, noted that while the medications could potentially cause gastroparesis, the condition could also be triggered by an undiagnosed illness or by the patient’s own diabetes, with the medications exacerbating the problem. The FDA has committed to ongoing monitoring of potential adverse events linked to these medications.Â
This unfolding legal drama underscores the potential risks associated with diabetes medications and raises critical questions about the duty of pharmaceutical companies to fully disclose potential side effects. It also highlights the importance of continuous monitoring and research to ensure the safety and efficacy of these medications.Â
