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FDA calls for expanded Byetta precautions

The FDA has revealed it suspects a link between usage of Byetta (exenatide injection), a type 2 diabetes drug, and acute pancreatitis.

The FDA has revealed it suspects a link between usage of Byetta (exenatide injection), a type 2 diabetes drug, and acute pancreatitis.

The FDA said it reviewed 30 reports of acute pancreatitis in patients taking Byetta and added: "An association between Byetta and acute pancreatitis is suspected in some of these cases."

Officials said the maker of Byetta, Amylin, has agreed to include information about acute pancreatitis in the precautions section of the product's label.

"Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Byetta to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting," the FDA said.

On 10 October 2007, Amylin's co-marketing partner Lilly launched Byetta in India. India becomes the fourth major launch in the world after the US, UK and Germany where Byetta is now available.

30th September 2008

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