On August 18, 2008, the FDA issued an alert to healthcare providers about six additional cases of necrotizing or hemorrhagic pancreatitis among users of Byetta, two of which have resulted in death. The warning follows a prior alert issued by the FDA in October 2007, involving at least 30 other cases that suggested an association between the diabetes drug Byetta and pancreatitis.
Byetta, which is the brand name of exenatide, is a subcutaneous injection administered twice a day to help reduce blood sugar levels in people with type 2 diabetes. It belongs to a class of drugs called incretin mimetics, which mimic the action of endogenous incretin hormones like GIP and GLP-1, which are found in the gastrointestinal tract. These peptides lower blood glucose levels by stimulating insulin secretion from pancreatic cells.
The FDA approved Byetta for treatment of Type 2 diabetes in April 2005, and it has been used by approximately 700,000 people in the United States. It is manufactured and marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., with annual sales of $636 million last year.
The FDA has recommended that healthcare providers stop their patients from using Byetta if they suspect the development of pancreatitis. If pancreatitis is confirmed or if a patient has a history of pancreatitis, the FDA indicates that another anti-diabetes drug should be used. Also, patients have been urged to report any Byetta side effects, including unexplained severe pain in the abdomen, either with or without vomiting.
Acute, hemorrhagic and necrotizing pancreatitis are very severe forms of pancreatitis, which is an inflammation of the pancreas. Hemorrhagic pancreatitis leads to severe bleeding caused by massive erosion of blood vessels. Necrotizing pancreatitis involves tissue damage, which leads to release of toxins and enzymes into the bloodstream and may cause multi-organ failure and death. None of the severe forms are easily distinguishable from normal pancreatitis.
Out of the most recent reports of 6 cases involving hemorrhagic or necroitzing pancreatitis from a side effect of Byetta, all of the patients were hospitalized for their injuries. Two have died and four were still recovering at the time of the FDA alert.
The FDA indicates that they are working with Amylin Pharmaceuticals, Inc. to develop stronger warnings about the Byetta pancreatitis side effects, which could be placed more prominently on the product’s label.