FDA Orders Revisions to Januvia and Janumet Labeling for Acute Pancreatitis
The Food and Drug Administration is warning about dozens of cases of acute pancreatitis reported in people taking the Type 2 diabetes drugs Januvia and Janumet.
Januvia (sitagliptin) and Janumet (sitagliptin/metformin) belong to a new class of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, which are prescribed along with diet and exercise to improve glycemic control in adult diabetics.
According to an FDA notice released today, from October 2006 to February 2009, there have been 88 reports of acute pancreatitis in patients taking Januvia and Janumet. Two-thirds of the patients required hospitalization, including four who were admitted to the intensive care unit.Two of the cases involved hemorrhagic or necrotizing pancreatitis, a severe form of the disease, the FDA said.
Acute pancreatitis is a sudden and painful inflammation of the pancreas that can range from mild to severe, life-threatening complications.
Changes Ordered to Prescribing Information
The FDA is ordering the makers of Januvia and Janumet to make changes to the drugs’ prescribing information to reflect the pancreatitis risks. The changes should include:
• Information regarding post-marketing reports of acute pancreatitis, including the severe forms, hemorrhagic or necrotizing pancreatitis.
• Recommending that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin, and to discontinue sitagliptin or sitagliptin/metformin if pancreatitis is suspected while using these products.
• Information noting that 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 while using sitagliptin or sitagliptin/metformin. Sitagliptin or sitagliptin/metformin should be used with caution and with appropriate monitoring in patients with a history of pancreatitis.
The FDA also is advising physicians to keep an eye on Januvia and Janumet patients for signs and symptoms of acute pancreatitis.
Other Diabetes Drugs Linked to Pancreatitis
People taking medications to treat Type 2 diabetes have long been at increased risks of pancreatitis and other serious medical complications.
In May, a study found that people taking the diabetes drug Byetta were about three times more likely to develop acute pancreatitis and gallbladder disease. Multiple studies have found a link between Byetta and disease of the pancreas, among other medical problems.
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