ROCKVILLE, Md -- September 25, 2009 -- The US Food and Drug Administration (FDA) is notifying healthcare professionals of revisions to the prescribing information for sitagliptin (Januvia) and sitagliptin/metformin (Janumet) to include information on reported cases of acute pancreatitis in patients using these products.
A total of 88 post-marketing cases of acute pancreatitis, including 2 cases of haemorrhagic or necrotising pancreatitis in patients using sitagliptin, were reported to the FDA between October 2006 and February 2009.
It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin.
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.
Considerations for Healthcare Professionals:
· Be aware of the possibility for and monitor for the emergence of the signs and symptoms of pancreatitis such as nausea, vomiting, anorexia, and persistent severe abdominal pain, sometimes radiating to the back.
· Discontinue sitagliptin or sitagliptin/metformin if pancreatitis is suspected.
· Understand that if pancreatitis is suspected in a patient, supportive medical care should be instituted. The patient should be monitored closely with appropriate laboratory studies such as serum and urine amylase, amylase/creatinine clearance ratio, electrolytes, serum calcium, glucose, and lipase.
· Inform patients of the signs and symptoms of acute pancreatitis so they are aware of and able to notify their healthcare professional if they experience any unusual signs or symptoms.
Background and Data Summary:
The 88 cases of acute pancreatitis in patients using sitagliptin or sitagliptin/metformin were reported to the FDA’s Adverse Event Reporting System (AERS) between October 2006 and February 2009. Hospitalisation was reported in 58 of 88 patients (66%), 4 of whom were admitted to the intensive care unit (ICU). Two cases of haemorrhagic or necrotising pancreatitis were identified in the review and both required an extended stay in the hospital with medical management in the ICU. The most common adverse events reported in the 88 cases were abdominal pain, nausea, and vomiting.
In addition, the analysis found that 19 of the 88 reported cases (21%) of pancreatitis occurred within 30 days of starting sitagliptin or sitagliptin/metformin. Furthermore, 47 of the 88 cases (53%) resolved once sitagliptin was discontinued. It is important to note that 45 cases (51%) were associated with at least 1 other risk factor for developing pancreatitis, such as diabetes, obesity, high cholesterol, and/or high triglycerides.
SOURCE: US Food and Drug Administration
