NEW ORLEANS (CN) – A federal class action claims that Eli Lilly and Amylin Pharmaceuticals failed to warn that their diabetes drug, Byetta, can cause sometimes-fatal pancreatitis.
Plaintiffs claim that post-marketing reports to the FDA in 2008 revealed six cases of hemorrhagic of necrotizing pancreatitis, two fatal, and all requiring hospitalization.
They claim a 2007 FDA review showed 30 reports of acute pancreatitis “and suspected an association between Byetta and acute pancreatitis”. They say the FDA asked the defendants to include “stronger warnings for acute pancreatitis,” but the defendants’ 2007 label mentioned only “acute pancreatitis,” without warning of its severity, and no “warning or precautions whatsoever regarding acute hemorrhagic and necrotizing pancreatitis.” They claim the FDA asked the defendants again in 2008 for “stronger and more prominent warnings with Byetta,” but they still failed to disclose the risk of acute hemorrhagic and necrotizing pancreatitis.
Plaintiffs say more than 4 million prescriptions for Byetta have been written. They demand refunds, disgorgement, stronger warning labels and punitive damages. They are represented by Michael Hingle of Slidell, La.