Nordisk and Eli Lilly are facing allegations that they failed to adequately caution patients about potential severe stomach issues linked to their widely used drugs, Ozempic and Mounjaro, in a lawsuit filed on Wednesday.
The lawsuit, spanning 26 pages and filed on behalf of a Louisiana resident who claims significant harm from taking both diabetes medications, marks the first legal action asserting gastrointestinal injuries stemming from these drugs.
Ozempic and Mounjaro belong to a novel category of medicines termed GLP-1 agonists, primarily prescribed to help individuals with Type 2 diabetes regulate blood sugar levels. Additionally, they are sometimes recommended off-label for weight management.
These medications function by slowing down the stomach's digestion process, leading to prolonged feelings of fullness. However, they also carry risks of gastrointestinal complications such as abdominal discomfort, nausea, and vomiting, as acknowledged in clinical trials and on the drugs’ labels.
Jaclyn Bjorklund, aged 44 and from Louisiana, alleges that the drug manufacturers failed to disclose additional health concerns associated with the drugs, including severe gastroparesis (stomach paralysis) and persistent vomiting, as stated by her attorney, Paul Pennock from the firm Morgan & Morgan.
Gastroparesis, a condition characterized by delayed emptying of the stomach, isn't explicitly mentioned in the prescribing information for Ozempic or Mounjaro. Still, both drugs' labels acknowledge delayed gastric emptying due to its potential impact on the absorption of other medications.
Eli Lilly declined to comment on the lawsuit, while Novo Nordisk stated they were unaware of it as of Wednesday morning, emphasizing that gastroparesis is a recognized risk for people with diabetes.
Pennock claims around 400 individuals have reported gastrointestinal injuries from these medications, with expectations for thousands more cases. Bjorklund, diagnosed with Type 2 diabetes in 2017 and a user of Ozempic and later Mounjaro, alleges severe injuries from the drugs, resulting in multiple emergency room visits due to severe stomach problems, including violent vomiting leading to tooth loss.
Although Bjorklund hasn't received a gastroparesis diagnosis, her symptoms align with the condition, according to Pennock, who dismisses the notion that her diabetes alone caused it.
Bjorklund is seeking substantial compensation from the drugmakers, though the exact amount remains unspecified.
Dr. Shauna Levy, a specialist in obesity medicine, expressed surprise at the lawsuit, suggesting that while the medications could contribute to gastroparesis, other factors such as undiagnosed conditions or the patient's diabetes might exacerbate the issue.
The FDA, through spokesperson Chanapa Tantibanchachai, stated they will continue monitoring for adverse events linked to these medications and will take appropriate actions based on thorough reviews of available evidence.
