FAQ's: Byetta

What is Byetta?

What injuries can Byetta cause?

What are the symptoms of Pancreatitis?

What are the symptoms of kidney failure?

What warnings have been issued by the FDA?

What is Byetta?

Byetta® (exenatide) is an injectable medication used to treat Type 2 (non-insulin dependent) diabetes. Byetta is manufactured by Amylin Pharmaceuticals, Inc. and Eli Lilly & Co. and was approved by the U.S. Food and Drug Administration in April 2005 to help reduce blood sugar levels. Byetta reduces blood sugar levels by stimulating insulin secretion from pancreatic cells.

What injuries can Byetta cause?

The use of Byetta has recently been linked to reports of serious and potentially life threatening injuries, including pancreatitis (acute, hemorrhagic, and/or necrotizing), impaired kidney dysfunction and kidney failure.

What are the symptoms of Pancreatitis?

Pancreatitis is an inflammation of the pancreas. In severe cases, bleeding, tissue damage, infection, and/or death may occur. Symptoms of pancreatitis may include:

• Severe abdominal pain
• Swollen or tender abdomen
• Nausea and vomiting
• Fever
• Rapid pulse
• High or low blood pressure

Necrotizing pancreatitis involves tissue damage, which leads to the release of toxins and enzymes into the blood stream and may cause multi-organ failure and death. Hemorrhagic pancreatitis is a severe form of the condition where erosion of blood vessels can lead to severe bleeding.

What are the symptoms of kidney failure?

The most common side effects suffered by those taking Byetta are nausea, vomiting and diarrhea, which may contribute to the development of altered kidney function. Signs of Byetta related kidney problems may include:

• Changes in urination (color, frequency, amount)
• Unexplained swelling in the extremities
• Changes in blood pressure
• Lethargy
• Changes in appetite or digestion
• Dull ache in mid to lower back

What warnings have the FDA issued about Byetta?

In October 2007, following the receipt of at least 30 reports of acute pancreatitis in patients taking Byetta, the FDA issued an alert about an association between Byetta use and pancreatitis. In August 2008, the FDA issued a second alert about an additional six reports of necrotizing pancreatitis or hemorrhagic pancreatitis in patients taking Byetta, two of which were fatal.  The FDA has subsequently warned healthcare professionals to discontinue Byetta if pancreatitis is suspected. If pancreatitis is confirmed, the FDA advised healthcare professionals not to restart Byetta following treatment.

In November 2009, the FDA announced that the Byetta label would be revised to include new safety information about possible kidney function problems, including kidney failure in patients taking Byetta.  This action was taken after the FDA received 78 reports of problems with kidney function, including 62 reports of kidney failure, in patients using Byetta between April 2005 and October 2008.

Read more information about Byetta Side Effects.