September 25, 2009- the Food and Drug Administration is revising the prescribing information for the type 2 diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis, a potentially life-threatening medical condition.

Januvia & Janumet Pancreatitis Reports

The FDA received 88 reports of acute pancreatitis with people taking Januvia and Janumet between October 16, 2006, and February 9, 2009. Some of the reports involved severe forms of pancreatitis, such as hemorrhagic pancreatitis (inflammation of the pancreas with bleeding) and necrotizing pancreatitis (in which the inflamed pancreas destroys itself).

After reviewing the reported cases of Januvia pancreatitis and Janumet pancreatitis, the FDA found that 19 (21%) of the 88 cases occurred within 30 days of starting Januvia or Janumet. Additionally, the FDA found that 47 (53%) of the 88 cases resolved themselves after Januvia or Janumet were discontinued. Based on these findings, the FDA says it believes there may be an association between Januvia, Janumet and the development of pancreatitis.

Because acute pancreatitis is associated with considerable morbidity and mortality, and early recognition is important in reducing adverse health outcomes, the FDA is making revisions to the Januvia and Janumet prescribing information to alert patients and healthcare professionals to this potentially serious side effect.

Januvia & Janumet Side Effects

While the FDA says that patients should not stop taking Januvia or Janumet without first speaking to a doctor, the agency recommends that patients pay close attention for any signs or symptoms of pancreatitis. Patients who experience any of the following Januvia side effects or Janumet side effects should contact a healthcare professional immediately:

  • nausea
  • vomiting
  • loss of appetite
  • persistent severe abdominal pain which may radiate to the back

Januvia & Janumet Side Effects Lawyer

If you or a loved one has experienced Januvia pancreatitis or Janumet pancreatitis, you may be entitled to compensation for your injuries. For more information about a Januvia lawsuit or Janumet lawsuit, contact one of Bernstein Liebhard’s attorneys for a free and confidential case evaluation.

Published November 17, 2011 by