Endocrine Insider
September 30, 2009

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Late last week, the U.S. Food and Drug Administration (FDA) released information for healthcare providers detailing new information on reported cases of acute pancreatitis in patients using sitagliptin (Januvia) and sitagliptin/metformin (Janumet). Sitagliptin is prescribed as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.

According to the FDA, eighty-eight post-marketing cases of acute pancreatitis in patients using sitagliptin, including two cases of hemorrhagic or necrotizing pancreatitis, were reported between October 16, 2006 and February 9, 2009. Based on this information, FDA began working with the drugs’ manufacturer to revise the prescribing information to include the following:

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

• A recommendation that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin, and to discontinue treatment with the drugs if pancreatitis is suspected.

• Information noting that sitagliptin and sitagliptin/metformin have not been studied in patients with a history of pancreatitis and should be used with caution and with appropriate monitoring in these patients.

For additional details on the FDA statement, including considerations for health care professionals and important information for patients, please click here.