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Januvia label revised to show risk of acute pancreatitis
The FDA notified patients and health care providers this week about changes in the prescription label for Januvia and Janumet (sitagliptin and sitagliptin/metformin) to include information on reported cases of acute pancreatitis. Between 2006-2009, there have been 88 post-marketing cases of acute pancreatitis including two cases of hemorrhagic or necrotizing pancreatitis.
Healthcare professionals have been advised to carefully monitor patients for the development of pancreatitis. It was also indicated that sitagliptin has not been studied in patients with a history of pancreatitis.