Januvia Patients Face Increased Risk of Pancreatitis

Boston, MAPatients who take type 2 diabetes drug Januvia could face an increased risk of pancreatitis. That was the word from the US Food and Drug Administration (FDA) back in 2009, after the agency received word of serious Januvia side effects, including a link between Januvia and pancreatitis.

Januvia was approved to treat adults with type 2 diabetes in 2006. By 2009, however, the FDA had received reports of 88 cases of acute pancreatitis in patients who used Januvia. Among the reports of pancreatitis were cases involving hemorrhagic or necrotizing pancreatitis. Patients were hospitalized in 66 percent of the cases of pancreatitis, and four of those patients were admitted to intensive care. An FDA analysis of the reports found that 21 percent of the cases occurred within one month of starting Januvia and approximately half the cases of pancreatitis resolved when the patient discontinued the medication.

When the FDA released information about Januvia, it noted that approximately half the patients who developed pancreatitis had at least one other risk factor for the condition, including obesity, high cholesterol and/or high triglycerides. This means that the medication may not be responsible for the development of pancreatitis, rather underlying conditions may also increase the risk of developing the condition.

"Based on the temporal relationship of initiating sitagliptin [the generic of Januvia] or sitapliptin/metformin [sold as Janumet] and the development of acute pancreatitis in the reviewed cases, FDA believes there may be an association between these events," the FDA stated. "Because acute pancreatitis is associated with considerable morbidity and mortality, and early recognition is important in reducing adverse health outcomes, FDA is recommending revisions to the prescribing information to alert healthcare professionals to this potentially serious adverse drug event."

When it issued its warning, the FDA announced the labels for Januvia and Janumet would be changed to include information on the risk of acute pancreatitis, including hemorrhagic or necrotizing pancreatitis. Furthermore, it recommended health care professionals closely monitor patients for signs of pancreatitis.

Symptoms of pancreatitis include nausea, vomiting, anorexia and severe, persistent abdominal pain.

Januvia is manufactured by Merck & Co. It and Janumet (a combination of sitagliptin and metformin) are in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors, used to control blood sugar in patients with type 2 diabetes.