FDA Drug Safety Communication

Since issuing a prior communication for Byetta in October 2007, FDA has received reports of six cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. 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.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no known patient characteristics which determine when pancreatitis associated with Byetta will be complicated by the hemorrhagic or necrotizing forms of this condition. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

FDA is working with the maker of Byetta, Amylin Pharmaceuticals, Inc., to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.

View the full FDA Drug Safety Communication on FDA.gov