Januvia
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 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.
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
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
