FDA Wants Pancreatitis Caution Added to Exenatide (Byetta) Label

ROCKVILLE, Md., Oct. 16 -- The FDA said today it has received 30 reports of acute pancreatitis in patients taking exenatide (Byetta) for treatment of type 2 diabetes.

Twenty-seven of the 30 patients had at least one other risk factor for acute pancreatitis such as gallstones, severe hypertriglyceridemia, and alcohol use.

In six patients the pancreatitis symptoms began or worsened soon after the dose of exenatide was increased from 5 mcg twice daily to 10 mcg twice daily. Twenty-one patients were hospitalized.

Although there were no reports of hemorrhagic or necrotizing pancreatitis, five patients developed serious complications including dehydration and renal failure; suspected ileus; phlegmon; or ascites.

Twenty-two of the 30 reports indicated that the patients improved after discontinuing exenatide.

Details in three reports indicated that the symptoms of acute pancreatitis returned when exenatide was restarted.

The FDA said the evidence suggests an association between exenatide and acute pancreatitis "in some of these cases."

The agency has asked Amylin Pharmaceuticals, maker of exenatide, to change the drug's label to include information about pancreatitis in the "Precautions" section.

The FDA has also recommended that physicians instruct patients taking the drug to seek medical care promptly if they have unexplained persistent severe abdominal pain, which may be accompanied by vomiting. The FDA said exenatide should be discontinued if pancreatitis is suspected. Moreover, exenatide should not be restarted in patients with acute pancreatitis unless "an alternative etiology is identified."