Users of the diabetes drugs Januvia or Janumet should be aware that the medications have been associated with a number of cases of pancreatitis, which may be caused by side effects of Januvia. The FDA issued an alert today to notify doctors and consumers about revisions to the warning label regarding post-marketing reports of acute pancreatitis, including severe forms, hemorrhagic pancreatitis and necrotizing pancreatitis.

>>FDA LINK: Januvia Pancreatitis Warning

Between October 2006 and February 2009, the FDA’s Adverse Event Reporting System has identified at least 88 cases of acute pancreatitis associated with the use of Januvia (sitagliptin) and Janumet, which combines Januvia with metformin. The actual number of Januvia pancreatitis cases is likely substantially higher, as reported events usually only account for between 1% and 10% of all occurrences.

Some concerning information provided by the FDA about the Januvia pancreatitis side effects include:

  • 66% of the cases resulted in hospitalization for pancreatitis
  • 4 cases required treatment in an intensive care unit (ICU)
  • 2 cases involved severe cases of hemorrhagic or necrotizing pancreatitis, which can be fatal in many cases
  • 21% of the cases had pancreatitis develop within 30 days of starting Januvia or Janumet
  • 53% of the cases resolved once the medication was stopped
  • 49% of the cases were not associated with other risk factors for developing pancreatitis
  • The most common pancreatitis symptoms from Januvia were abdominal pain, nausea and vomiting

According to the information provided to healthcare professions about the Januvia pancreatitis warning, the FDA concluded:

Based on the temporal relationship of initiating sitagliptin (Januvia) or sitagliptin/metformin (Janumet) and development of acute pancreatitis in 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.


The product liability lawyers at Saiontz & Kirk, P.A. are closely examining the information provided by the FDA and evaluating whether users of these diabetes drugs who have experienced a severe injury may be entitled to compensation through a Januvia lawsuit as a result of the drug maker’s failure to adequately warn about this serious and potentially life-threatening side effects.

The FDA has not indicated that any users of Januvia or Janumet should stop taking their medication, and no medication (especially a diabetes drug) should be discontinued without the supervision of a physician. Any concerns about the potential for Januvia pancreatitis side effects should be reviewed with a doctor.

Symptoms of pancreatitis could include:

  • Severe upper abdominal pain which may radiate through the back
  • Nausea and Vomiting
  • High or Low Blood Pressure
  • Elevated Heart or Respiratory Rates

If you, a friend or family member have been diagnosed with pancreatitis and wish to provide information about your potential claim to be reviewed by our Januvia lawyers as part of our evaluation of this litigation, request a free consultation and claim evaluation.