Lilly, Novo Nordisk sued over GLP-1 drug safety

A lawsuit has been filed in the US claiming that Novo Nordisk and Eli Lilly failed to warn of severe gastrointestinal side effects that can be caused by their incretin mimetic drugs, which are approved to treat diabetes.

Louisiana woman Jaclyn Bjorklund (44) took Novo Nordisk's GLP-1 agonist Ozempic (semaglutide) for a year for type 2 diabetes and later switched to using Lilly's combined GLP-1/GIP agonist Mounjaro (tirzepatide).

She is suing the two pharma companies for "downplaying" the risk of side effects, including gastroparesis, described in the complaint as paralysed stomach, and gastroenteritis, claiming she suffered "severe gastrointestinal events, and as a result sustained severe and permanent personal injuries, pain, suffering, and emotional distress, and incurred medical expenses".

Lawyers for Morgan & Morgan, which is representing Bjorklund in the case and claims to be the US's largest personal injury law firm, told a press conference that she suffered severe vomiting due to gastroparesis after taking the drugs that resulted in her being hospitalised and losing teeth.

They said that the suit is an example of a "failure to warn" case, adding that the law firm has already signed up more than 400 other clients across 45 states who claim that they were harmed after taking the drugs, mainly as a result of gastroparesis.

That raises fears of expensive and time-consuming litigation for the two drugmakers and possibly others working on incretin drugs for diabetes and follow-up indications such as obesity.

Novo Nordisk already has approval for semaglutide under the Wegovy brand for obesity, while Lilly is in the process of seeking approval to add weight loss to the label of Mounjaro. Both drugs are known to cause delayed gastric emptying but don't have gastroparesis specifically mentioned as a side effect on the label. Mounjaro's label notes, however, that the drug is contraindicated in patients with gastroparesis.

Novo Nordisk sent pharmaphorum a statement noting that GLP-1 agonists have been used for years to treat type 2 diabetes and obesity, and semaglutide itself has racked up more than 9.5 million patient-years of exposure.

It also noted that gastroparesis can be associated with diabetes and that being overweight, female and having a viral infection or certain central nervous system disorders are also risk factors for developing the condition.

"Patient safety is of utmost importance to Novo Nordisk. We recommend patients take these medications for their approved indications and under the supervision of a healthcare professional," said a spokesperson.

"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," they added.

News of the lawsuit emerged shortly after Johnson & Johnson's second attempt to use a bankruptcy petition known as a 'Texas Two Step' to settle long-running litigation claiming that its talc products caused cancer was rejected.