Byetta May Cause Acute Pancreatitis

On August 18, 2008, the FDA advised healthcare professionals of six new reports of hemorrhagic or necrotizing pancreatitis associated with the use Byetta.  Byetta is a subcutaneous injection used to treat type 2 diabetes in adults.  Of these six cases, all patients required hospitalization, two patients died, and four were recovering at the time of this report.  This is an update following an alert from the FDA in October 2007 concerning 30 postmarketing reports of acute pancreatitis in patients taking Byetta.  Amylin Pharmaceuticals, Inc, the maker of Byetta has since posted information regarding acute pancreatitis in the Precautions section of the product label. 

Patients with acute pancreatitis present with mild to severe epigastric pain with radiation to the flank or back.  The pain is usually worsened when lying on the back and is often triggered by a heavy meal or drinking binge.  Nausea and vomiting may also occur in patients with acute pancreatitis. Acute pancreatitis is typically confirmed by the presence of elevated levels of serum amylase and/or lipase and characteristic findings by radiological imaging. Acute necrotizing pancreatitis is the most severe form of inflammation associated with pancreatitis.  Inflammation causes cell death with resultant devitalized tissue, which is likely to become infected.  An unexpectedly prolonged course, hemodynamic instability, fever, or the presence of fluid collections on a CT scan all point to the possibility of necrosis.  Acute hemorrhagic pancreatitis is a life-threatening condition with a mortality rate approaching 50% because of shock, systemic inflammatory response syndrome with multiple organ dysfunction, acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation, massive gastrointestinal bleeding, and systemic or peritoneal infection.  A sign of hemorrhagic pancreatitis includes a bluish discoloration of the flanks or periumbilical region, because of blood accumulation in the abdomen. Acute pancreatitis is a serious condition and if suspected, use of Byetta should be discontinued.

References:

• Information for Healthcare Professionals. Exenatide (marketed as Byetta). FDA. Available at: http://www.fda.gov/CDER/drug/InfoSheets/HCP/exenatide2008HCP.htm
• Munoz A, Katerndahl DA. Diagnosis and Management of Acute Pancreatitis. Am Fam Physician 2000;62:164-74.
• Thomson A, Frizzell ER. Pancreatic Necrosis and Pancreatic Abscess. EMedicine. Available at: http://www.emedicine.com/med/topic1711.htm
• Hebra A, Adams SD, Thomas PB. Pancreatitis and Pancreatic Pseudocyst. EMedicine. Available at: http://www.emedicine.com/ped/topic3014.htm

Michelle Kennedy, PharmD. Candidate