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Byetta®
Byetta® (exenatide), is an injectable diabetes medication that can help people with Type II Diabetes improve their long-term control of blood sugar levels. Byetta®, the trade name for exenatide, is an incretin mimetic, a non-insulin diabetes medication that helps control blood sugar by lowering post-meal and fasting glucose levels.
U.S. FDA ACTION
In late 2007, the FDA began to issue warnings that Byetta may cause pancreatitis. Pancreatitis is a painful inflammatory condition in which pancreatic digestive enzymes attack the pancreas itself. Pancreatitis can lead to severe complications, and can even be fatal. Acute pancreatitis is the swelling of the pancreas that can result in nausea, vomiting and severe abdominal pain. Although dependent of the severity of the pancreatitis, treatment requires hospitalization with pain management and fluid and electrolyte stabilization. In severe cases, treatment may require surgery or other invasive measures.
The first FDA advisory related to Byetta was issued in September 2007 - less than two years after the multinational pharmaceutical company Eli Lily and Amylin brought Byetta® to market. In October 2007, the FDA issued a warning that Byetta® may cause severe pancreatitits after it had received more than 30 reports of pancreatitis in Byetta® users. The FDA has received information on an additional six adverse reactions since the October 2007 announcement. Of those six patients, two died.
In August 2008, the FDA announced that pancreatitis-related injuries and deaths continue to rise as a result of Byetta. In the August 2008 announcement, the FDA and WEBMD reported that six more people were hospitalized for severe hemorrhagic or necrotizing pancreatitis. All six patients were using Byetta® when they developed pancreatitis. Two of those six patients died, and an additional four patients using Byetta have also died.
BYETTA SIDE EFFECTS
Byetta has been linked with a number of mild to moderate adverse side effects, including:
- heartburn
- indigestion (dyspepsia)
- nausea
- vomiting
- diarrhea; and
- stomach discomfort.
In addition, Hypoglycemia can occur when Byetta® is used with a sulfonylurea. Patients who have severe renal impairment or end-stage renal disease or are on dialysis face significantly higher risk of developing serious gastrointestinal side effects.
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