FDA Warns of Pancreatitis RiskAssociated With Diabetes Drug

By JENNIFER CORBETT DOORENOctober 16, 2007 3:01 p.m.
WASHINGTON -- The Food and Drug Administration said Tuesday it was alerting doctors and patients using the diabetes drug Byetta about the possibility the drug might cause acute pancreatitis, an inflammation of the pancreas that can be fatal.
Byetta is co-marketed by Amylin Pharmaceuticals Inc., based in San Diego, and Eli Lilly & Co. of Indianapolis. It was approved in 2005.
The FDA said it reviewed 30 post-marketing reports of acute pancreatitis, which the agency said could be associated with the use of Byetta. The agency said Amylin has agreed to update Byetta's label to discuss the possibility it could contribute to or cause pancreatitis.
Alice Bahner Izzo, an Amylin spokeswoman, said information about pancreatitis is already on Byetta's label, but that it is being updated to give clear advice on what signs and symptoms doctors should look for. "It's a rare but serious event," Ms. Izzo said of pancreatitis. Byetta has been used by 700,000 patients in the U.S. since the drug was introduced.
The FDA said doctors and patients need to be alert to the signs and symptoms of acute pancreatitis, which include persistent, severe abdominal pain that can radiate to the back and may be accompanied by nausea and vomiting. Tests are needed to confirm acute pancreatitis. The agency noted that commonly reported side effects of Byetta include nausea, vomiting, diarrhea, indigestion and upper abdominal discomfort, but that the pain associated with acute pancreatitis is more persistent and severe.
The agency said a patient's use of Byetta should be stopped if pancreatitis is suspected. If it is confirmed, the drug shouldn't be restarted unless a different link to the cause of pancreatitis can be found.
The FDA said that, of the 30 reports of pancreatitis, 27 patients had at least one other risk factor for developing the condition, such as gallstones or alcohol use. In six cases symptoms of pancreatitis began or worsened soon after the dose of Byetta was increased from 5 micrograms twice daily to 10 micrograms twice daily, the FDA said. In 22 of the 30 cases, reports indicated patients improved after discontinuing Byetta.
Byetta, an injection taken before morning and evening meals, was approved for use in people with type 2 diabetes who weren't able to have their blood-sugar or blood-glucose levels effectively lowered with other diabetes medications. People with type 2 diabetes either don't produce enough insulin or cannot properly use it. Insulin, produced by the pancreas, is needed to take sugar from blood into cells.
Byetta is a synthetic form of a hormone taken from a lizard that's similar to a human hormone in the digestive tract known as GLP-1. The hormone works to boost the production of insulin in order to regulate blood-sugar levels.