Diabetes drug under scrutiny by FDA

August 22, 2008

FDA scrutinizes Byetta, a diabetes drug from Eli Lilly and Amylin, following reports of deaths.

The U.S. Food & Drug Administration is planning to issue a mandate for a revised label for a commonly used diabetes drug from Amylin Pharmaceuticals and Eli Lilly & Co. following reports of deaths despite earlier government warnings.

Six new reports have been filed with FDA regarding patients developing a potentially fatal form of pancreatitis while taking Byetta. Two patients died; four are recovering.

In a statement, the drugmakers noted that those taking Byetta have shown "very rare case reports of pancreatitis with complications or with a fatal outcome." Further, the companies state that these patients are already at increased risk of pancreatitis compared with patients who do not have diabetes.

Patients are urged by FDA to halt use of Byetta immediately if they develop signs of acute pancreatitis.

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