FDA Warns of Acute Pancreatitis Reported with Januvia and Janumet

The Food and Drug Administration (FDA) is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products.

Sitagliptin, the first in a new class of diabetic drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Eighty-eight post-marketing cases of acute pancreatitis, including 2 cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 16, 2006 and February 9, 2009.

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Published on Sep-28-09