Another type 2 diabetes treatment may be slapped with new warnings by the Food and Drug Administration (FDA). The agency has asked Amylin Pharmaceuticals Inc. to include information about pancreatitis among the “precautions” on the label of its drug Byetta (exenatide) based on a large study.
Pancreatitis is an inflammation of the pancreas that requires immediate medical attention and hospitalization during an attack. Symptoms include upper abdominal pain that radiates into the back, swollen and tender abdomen, nausea and vomiting, fever, and increased heart rate. In some cases, the pain with pancreatitis may be debilitating.
According to the study, 30 cases of pancreatitis were reported among patients who were using Byetta. Symptoms got worse after the dose of Byetta was increased from 5 micrograms twice daily to 10 micrograms twice daily. Of the 30 patients who developed pancreatitis, 21 were hospitalized, and five developed serious complications such as dehydration, kidney failure, intestinal obstruction, tissue inflammation, and abnormal fluid buildup in the abdomen.
Twenty-two of the patients improved after they discontinued Byetta therapy. In the nine other cases, symptoms of pancreatitis returned after Byetta therapy was started again.
Byetta has also been associated with an increased risk for thyroid cancer and impaired kidney function.
Byetta is the latest type 2 diabetes medication to be singled out for serious side effects. In 2010, the FDA severely restricted Avandia after the drug was tied to fatal heart attacks. In 2011, the FDA warned that Actos increased the risk for bladder cancer, especially in patients who used the drug long term.
Source: Diabetes Self Management