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FDA Drug & Medical Device Recall News & Comments 
Wednesday, May 06 2009

Byetta Side Effects of Pancreatitis

Last year in August 2008, the FDA issued additional warnings due to additional reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta.The FDA reported of 6 Byetta cases of hemorrhagic or necrotizing pancreatitis in which all 6 patients required hospitalization, two patients died and four patients were recovering at time of reporting. The FDA stopped short of issuing an official Byetta Black box warning, the strongest FDA warning that can be imposed, short of a Byetta recall, but the FDA indicated it was working with Amylin to add stronger and more prominent warnings on the product label about the risk serious and possible Byetta side effects including acute hemorrhagic and necrotizing pancreatitis. See: Byetta Pancreatitis Side Effects

Posted by: DW AT 08:05 am   |  Permalink   |  Email
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