Byetta Associated with Necrotizing Pancreatitis

Lawyers and Attorneys working for our firm have been investigation claims that Byetta caused necrotizing pancreatitis since the FDA issued information for healthcare professionals in October 2007.  Since then the FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases. Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis. 

FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases. Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label. 

Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Byetta to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.

WHAT IS NECROTIZING PANCREATITIS?

Necrotizing Pancreatitis is the most severe end of a spectrum of inflammation associated with pancreatitis. Inflammation causes cell death with resultant dead tissue, which is likely to become infected. The amount of necrotic tissue is the strongest predictor of mortality in necrotizing pancreatitis. After pancreatic necrosis occurs, 3 potential outcomes exist, resolution, pseudocyst, or abscess. 

• A pseudocyst is a collection of fluid surrounding the pancreas.  

• A pancreatic abscess is a collection of pus resulting from tissue death and infection.  

Pancreatic abscess is a late complication of acute necrotizing pancreatitis, occurring more than 4 weeks after the initial attack. The mortality rate associated with pancreatic abscess is generally less than that of infected necrosis. The mortality rate of pancreatitis may exceed 20% or more with infected pancreatic necrosis and is largely related to sepsis and multiorgan failure.

SIGNS AND SYMPTOMS OF NECROTIZING PANCREATITIS

Signs and symptoms of necrotizing pancreatitis include:

• Abdominal pain;
• Fever or low body temperature (hypothermia);
• Fast heart rate;
• Rapid breathing;
• Change in mental status, such as confusion or decreased alertness;
• Diarrhea;
• Low blood pressure — dizziness when you stand up;
• Warm, flushed skin or skin rash or bleeding; and 
• Decreased urine output.