Diabetes Medication Byetta Linked to Pancreatitis, FDA Orders Stronger Label Warning
Byetta, a Type 2 diabetes drug made by Amylin Pharmaceuticals, Inc., has been linked to six cases of hemorrhagic or necrotizing pancreatitis. Two patients have died and four others are recovering after being hospitalized, according to the U.S. Food and Drug Administration.
The recent incidents have prompted the FDA to develop stronger, more prominent warnings for the product’s label to alert consumers about the risk of acute hemorrhagic or necrotizing pancreatitis. Physicians are being cautioned to consider anti-diabetic therapies other than Byetta in patients with a history of pancreatitis.
The FDA warning comes less than a year after a link between Byetta and pancreatitis was first revealed by federal regulators. In October 2007, the FDA announced it had reviewed 30 cases of the condition in Byetta patients. At that time, the FDA asked Amylin Pharmaceuticals, Inc. to include information about acute pancreatitis in the precautions section of Byetta’s labeling.
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Permalink Tags: amylin pharmaceuticals, byetta, fda, hemorrhagic, necrotizing pancreatitis
