The Food and Drug Administration is warning doctors and patients of diabetic drug, Byetta, which may cause acute pancreatitis, an inflammation of the pancreas that can be fatal.
The drug, approved in 2005, may be associated with 30 reports of acute pancreatitis, following use of type 2 diabetes drug. In the reports, 27 of the patients also had at least one other risk factor for developing the pancreatitis, including gall stones or alcohol use, according to the FDA. However, in six of the other cases, the pancreatitis worsened after a Byetta dosage was increased, the FDA said. The drug has been used by more than 700,000 patients since its introduction.
Byetta, a synthetic hormone taken from a lizard, which is similar to a human hormone, is an injection taken before morning and evening meals. The hormone is recommended for patients with type 2 diabetes, who cannot lower their blood-sugar and blood-glucose levels with other diabetes drugs. The hormone helps to boost the production of insulin to better regulate blood-sugar levels.
The drug company, Amylin, which co-markets the drug with Eli Lilly, has agreed to update the Byetta label to include possible risk of pancreatitis. The most common side effects currently reported include nausea, vomiting, diarrhea, indigestion and upper abdominal discomfort. However, acute pancreatitis pain can be more severe.
The FDA is urging doctors and patients to be aware of some of the signs and symptoms of acute pancreatitis, which include persistent, severe abdominal pain that can travel to the back and may be accompanied by nausea and vomiting.