FDA Reports Deaths With Diabetes Drug Byetta

FDA Reports Deaths With Diabetes Drug Byetta

http://abcnews.go.com/Health/DiabetesNews/wireStory?id=5604366

FDA Reports Deaths With Diabetes Drug Byetta
FDA working on new warning label for Amylin, Eli Lilly drug Byetta after deaths reported
By MATTHEW PERRONE AP Business Writer
WASHINGTON August 18, 2008 (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 were reported with the medication 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.

Regulators stressed that patients should stop taking Byetta immediately if they develop signs of acute pancreatitis, a swelling of the pancreas that can cause nausea, vomiting and abdominal pain. The FDA warned that it is very difficult to distinguish acute pancreatitis from less dangerous forms of the condition.

The FDA announcement updated an October alert about 30 reports of Byetta patients developing pancreas problems. None of those cases were fatal, but Byetta's makers agreed to add information about the reports to the drug's label.