The FDA has notified healthcare professional and patients of revisions to the prescribing information for Merck’s Januvia (sitagliptin tablets) and Janumet (sitagliptin/metformin tablets) to include information on reported cases of acute pancreatitis in patients treated with these medications. The FDA has received reports of 88 post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, between October 2006 and February 2009. The FDA is recommending that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of Januvia or Janumet. 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 and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis.
Januvia is indicated as an adjunct to diet and exercise in type 2 diabetes, as monotherapy or combination therapy. Janumet is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183800.htm.