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Diabetes Medication Byetta Has Been Related To Hemorrhagic Pancreatitis And Necrotizing Pancreatitis

Six Case Reports Made To FDA Since October 2007 "Dear Doctor" Letter About Acute Pancreatitis In Patients Taking Byetta

In August 2008 the FDA issued a MedWatch alert regarding Byetta (exenatide) which informed us that the agency had received reports about six cases of hemorrhagic pancreatitis or necrotizing pancreatitis since October 2007.

In more detail, on August 18, 2008 the FDA updated its "Information for Healthcare Professionals" page for Byetta and provided some details about these six cases by means of the following excerpts:

  • Since issuing Exenatide (marketed as Byetta)- Information for Healthcare Professionals (10/2007) in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 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 6 cases.

  • 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.

As background, in October 2007 the FDA issued an alert to inform doctors about 30 reports of acute pancreatitis in patients taking Byetta which had been received by the agency since Byetta was approved by the FDA on April 28, 2005 to treat adults with type 2 diabetes.

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