August 18, 2008 WASHINGTON (AP) -- Federal regulators are working on a stronger label for a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. after deaths continue to be reported despite earlier government warnings.
The Food and Drug Administration said Monday it has received six new reports of patients developing a dangerous form of pancreatitis while taking Byetta. Two of the patients died and four were recovering.
The drugmakers said in a statement that patients taking Byetta have shown "very rare case reports of pancreatitis with complications or with a fatal outcome." The companies added that diabetes patients are already at increased risk of pancreatitis compared with healthy patients.
The FDA announcement updated an October alert about 30 reports of Byetta patients developing the ailment. Regulators stressed that patients should stop taking Byetta immediately if they develop signs of acute pancreatitis, which can cause nausea, abdominal pain and potentially deadly complications.
More than 700,000 patients worldwide have used the injectable drug since it was launched in June 2005. It is marketed for patients with type 2 diabetes by San Diego-based Amylin and Eli Lilly.
Shares of Amylin Pharmaceuticals fell $5.59, or 16.3 percent, to $28.62 in afternoon trading, while Indianapolis-based Eli Lilly dipped 80 cents to $47.98.
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