On August 18, 2008, the Food and Drug Administration (FDA) reported it received reports of six cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta, a drug used to treat adults with type 2 diabetes. Two of the cases resulted in death, and the four others required hospitalization.

The FDA also reported it is working with the maker of Byetta, Amylin Pharmaceuticals, Inc., to add stronger and more prominent warnings about the risk of acute pancreatitis on the drug’s label.

The report came 10 months after an alert from the FDA warning healthcare professionals and consumers about the risk of pancreatitis in Byetta patients.

Byetta is a medicine given by injection to adults diagnosed with type 2 diabetes. Some patients have reported having severe, abdominal pain, raising the suspicion of acute pancreatitis. Byetta has prompted 30 postmarketing reports of acute pancreatitis, with 22 of the reports indicating patient improvement after discontinuing the drug.

Source: “Information for healthcare professionals: Exenatide (marketed as Byetta),” Food and Drug Administration Information Sheet, August 18, 2008.