Januvia Patients Should Be Aware of Pancreatitis

Boston, MAPatients taking Januvia should be aware of serious Januvia side effects, which include an increased risk of Januvia pancreatitis, according to the US Food and Drug Administration (FDA). On September 25, 2009, the FDA announced it was requiring the prescribing information for Januvia (known generically as sitagliptin) and Janumet (a combination of sitagliptin and metformin) to include information about cases of acute pancreatitis in patients who used those products.

Sitagliptin was the first of a new class of diabetes drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. They are meant to be used along with diet and exercise to improve glycemic control in adults who have type 2 diabetes.

The revised label was announced after FDA received 88 reports of acute pancreatitis, including two instances of hemorrhagic or necrotizing pancreatitis, in patients who received sitagliptin between October 16, 2006 and February 9, 2009. According to a report by The Wall Street Journal (09/25/09), although none of the reports of pancreatitis involved death, approximately 65 percent of the reports involved hospitalization and approximately half the cases resolved after the patient discontinued the medication. Around 20 percent of the cases of pancreatitis began within one month of starting the medication.

Merck, maker of Januvia, defended the drug, noting that diabetes itself increases the risk of pancreatitis.

Pancreatitis is an inflammation of the pancreas that can be life threatening. Symptoms of acute pancreatitis include severe, persistent abdominal pain, sometimes accompanied by vomiting. That pain may in some patients radiate to the back.

In February 2010, Merck issued a Risk Evaluation and Mitigation Strategy (REMS) for Januvia. The goal of the REMS was to ensure that patients were aware of the serious risks associated with use of the drug. The REMS includes ensuring that the Medication Guide is given out with every Januvia prescription, providing pharmacies with copies of the Medication Guide so they can be directly given to patients, and assessment of the REMS at 18 months, three years and seven years from the date the REMS was approved.

A study, published in the journal Diabetes (04/29/09), found that the negative actions of sitagliptin on the patient's pancreas, "raise concerns that require further evaluation." The study found that use of sitagliptin was associated with "increased pancreatic ductal turnover… and, in one rat, pancreatitis."

Furthermore, abnormalities that appeared in the pancreas are linked to a greater risk of pancreatic cancer over time. The study found that rats given sitagliptin alone, as opposed to in combination with metformin, had unusually high rates of cell production in the ducts of their pancreas.