Lawsuit filed on heels of updated warning for diabetes drug
|More trouble unfolding for Byetta, the injectable type 2 diabetes treatment. Source: Healthcare Packaging|
The plaintiff, Victor Deleon, alleges in a lawsuit filed in San Diego Superior Court that the manufacturer of the drug, San Diego-based Amylin Pharmaceuticals, and its co-marketer, the Deerfield, Ill.-based Eli Lilly, failed to adequately test and monitor the side effects of Byetta, and did not warn doctors or patients of the risk of developing pancreatitis.
On Monday, the FDA updated healthcare professionals that it had received reports of six cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta in October 2007. Of the six cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all six cases.
The FDA said it is “working with the maker of Byetta” to add “stronger and more prominent warnings” to the product's label.
Deleon's lawsuit alleges that Amylin “failed to adequately warn prescribing physicians of the risk of pancreatitis, of measures needed to properly assess the appropriateness of prescribing the drug to certain categories of patients, and of measures doctors and patients could and should take to minimize the risk.”
In the fall of 2007, Amylin had agreed to add information about pancreatitis to the precautions section of the Byetta label after the FDA reported 30 post-marketing reports of acute pancreatitis associated with the drug, according to the lawsuit.
"It is pretty obvious that the label change in 2007 was not adequate," said Thomas M. Moore of Moore Labriola of Newport Beach, Calif., who represents Deleon. “We believe that Amylin possessed data prior to the 2007 label revision that justified a stronger and more prominent warning than the precaution language that Amylin ultimately negotiated with FDA,” according to Moore.