FDA Announcement Regarding Exenatide (Marketed as Byetta)

Since issuing Information for Healthcare Professionals in October 2007, the FDA has received reports of six cases nationwide of hemorrhagic or necrotizing pancreatitis in patients taking Byetta -- a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the six cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at the 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 signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider anti-diabetic therapies other than Byetta in patients with a history of pancreatitis.

Click on the link below to read the complete MedWatch 2008 Safety Summary at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Byetta