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  • FDA Date: 09/25/2009

    Janumet (sitagliptin/metformin HCl) FDA Drug Safety Communication

    Information for Healthcare Professionals: Acute pancreatitis and sitagliptin (marketed as Januvia and Janumet)

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include the following:

    - Information regarding postmarketing reports of acute pancreatitis, including the severe forms, hemorrhagic or necrotizing pancreatitis.

    - Recommending that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin, and to discontinue sitagliptin or sitagliptin/metformin if pancreatitis is suspected while using these products.

    - Information noting that sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis while using sitagliptin or sitagliptin/metformin. Sitagliptin or sitagliptin/metformin should be used with caution and with appropriate monitoring in patients with a history of pancreatitis.

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

    View the full FDA Drug Safety Communication on FDA.gov