Another Diabetes Drug Linked to Acute Pancreatitis

The prescribing information for the type 2 diabetes drug sitagliptin (marketed alone as Januvia, and combined with metformin as Janumet) must be revised to note the incidence of acute pancreatitis in some patients using the drug, the FDA announced on Friday.

Some 88 cases have been reported since sitagliptin was approved in 2006; two cases were necrotizing or hemorrhagic pancreatitis. Overall, 20% occurred within a month of drug initiation, and about half resolved after drug discontinuation.

The FDA advises healthcare providers to monitor patients on sitagliptin for signs of pancreatitis (e.g., abdominal pain, nausea, vomiting), and to discontinue the drug if pancreatitis is suspected. Patients should also be educated about these symptoms.

It is not known whether sitagliptin users with histories of pancreatitis are at increased risk for the condition, the FDA says.