Alerts
Sitagliptin (Januvia) and sitagliptin/metformin (Janumet) – Reports of Acute Pancreatitis
9/29/2009
FDA and the manufacturer of sitagliptin (Januvia®) and sitagliptin/metformin (Janumet®) are making changes to the prescribing information to include information about pancreatitis. Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise for the treatment of diabetes. Acute pancreatitis occurred in 88 patients taking sitagliptin or sitagliptin/metformin between October 2006 and February 2009, including two cases of severe pancreatitis.
Revised prescribing information will include information regarding the post-marketing reports of pancreatitis, recommendations to monitor patients for signs of pancreatitis, especially during therapy initiation and dose increases, and to discontinue treatment with sitagliptin if pancreatitis is suspected.
The risks of sitagliptin use in patients with a history of pancreatitis is unknown. FDA recommends using sitagliptin with caution in this population.
Providers are urged to educate patients about the signs and symptoms of acute pancreatitis including nausea, vomiting, and persistent severe abdominal pain. Instruct patients to immediately notify their prescriber if they develop these symptoms. FDA recommends that providers immediately discontinue sitagliptin and monitor suspected cases of acute pancreatitis with appropriate laboratory tests.
- Medwatch safety alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183800.htm - Information for Healthcare Professionals:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm183764.htm
Updated
September 29, 2009; Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
