Six deaths in patients using the new diabetic drug Byetta have been reported. The deaths were caused by pancreatitis. The FDA is working with the manufacturer of the drug on stronger and more prominent warnings about the risk of pancreatitis with the use of Byetta.

Byetta was the first of a class of drugs called incretin mimetics introduced for the treatment of type 2 diabetes. Byetta is given by subcutaneous injection. It works by mimicking naturally occurring hormones in the intestines that signal fullness, slow gastric emptying, and signal the need to release insulin from the pancreas.

The patients who died developed a serious form of pancreatitis called acute hemorrhagic or necrotizing pancreatitis. Pancreatitis is an inflammation of the pancreas. The pancreas is a large gland behind the stomach that secretes digestive enzymes into the intestines. These enzymes help digest fats, proteins, and carbohydrates in food. The pancreas also releases the hormones insulin and glucagon into the bloodstream. These hormones help the body use the glucose it takes from food for energy.

There is no way to distinguish signs or symptoms of less severe forms of pancreatits from the more severe life-threatening necrotizing pancreatitis. Byetta should be discontinued immediately if signs of pancreatitis occur. Symptoms of pancreatitis include pain in the upper abdomen that lasts for a few days. The pain may be constant and severe. The pain can begin either as a mild pain that worsens when food is eaten or may be sudden and intense. Other symptoms include a swollen and tender abdomen, nausea, vomiting, fever, and rapid pulse. Severe cases can cause dehydration, low blood pressure, and shock. If pancreatitis is confirmed, appropriate treatment and monitoring should begin. Treatment is usually supportive, such as intravenous fluids, to prevent involvement of other organs. Byetta should not be restarted. Byetta should not be used in patients with a history of pancreatitis. A number of similar products are currently being considered for approval by the FDA to treat type 2 diabetes.

Patients using Byetta are encouraged to talk to their health care providers before changing anything in their treatment plan.

References: http://www.fda.gov/cder/drug/infopage/exenatide/default.htm, http://drugtopics.modernmedicine.com/drugtopics/article/articleDetail.jsp?id=543944, http://diabetes.webmd.com/news/20080818/fda-notes-two--byetta-deaths.

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