FDA wants diabetes drug pancreatitis warning

• Tweet

WASHINGTON, Aug. 18 (UPI) -- The U.S. Food and Drug Administration has asked the maker of the type 2 diabetes drug Byetta to include a warning for acute pancreatitis, officials said.

Six cases of pancreatitis have been reported by patients taking Byetta, or exenatide, with four patients recovering, MedPage Today reported.

Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the precautions section of the product label.

From Apr. 28, 2005, to Dec. 31, 2006, the FDA received 30 domestic reports of acute pancreatitis in patients who received exenatide treatment. The age of patients was age 43 to 72.

The daily dose of exenatide was reported in 25 of the cases and ranged from 10 to 20 mcg. The median time to onset of symptoms of acute pancreatitis from the start of exenatide therapy was 34 days although the range was four to 300 days. A dose-response relationship was observed in six patients who reported the onset or worsening of symptoms associated with acute pancreatitis soon after the dose was increased from 5 mcg twice daily to 10 mcg twice daily, the FDA said.

If patients taking exenatide experience unexplained persistent severe abdominal pain, they should seek prompt medical attention, the FDA said.