The FDA ( Food and Drug Administration ) has completed a review of 88 cases of acute pancreatitis in patients using Sitagliptin ( Januvia ) or Sitagliptin / Metformin ( Janumet ). The cases were reported to FDA’s Adverse Event Reporting System ( AERS ) between October 2006 and February 2009.

Hospitalization was reported in 58/88 ( 66% ) of the patients, 4 of whom were admitted to the intensive care unit ( ICU ). Two cases of hemorrhagic or necrotizing 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.

Additionally, 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 one other risk factor for developing pancreatitis, such as diabetes, obesity, high cholesterol and/or high triglycerides.

Based on the temporal relationship of initiating Sitagliptin or Sitagliptin / Metformin and development of acute pancreatitis in the reviewed cases, FDA believes there may be an association between these events. 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.

Source: FDA, 2009

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