FDA has issued two warnings regarding serious Byetta side effects of acute pancreatitis, as well as hemorrhagic pancreatitis and necrotizing pancreatitis. Pancreatitis is an inflammation of the pancreas that can cause bleeding, tissue damage and infection. At least two people have died as a result of Byetta-associated pancreatitis as a severe cases of pancreatitis can lead to the release of toxins and enzymes into the blood stream that can injure the heart, lungs, kidneys or other organs resulting in panceatic death.

FDA Byetta Alert of Serious & Fatal Side Effects of Pancreatitis

In August of 2008, the FDA issued additional warnings due to additional reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. In the cases involving Byetta side effects, the 6 Byetta cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. The FDA stopped short of issuing an official Byetta Black box warning,  but indicated it was working with Amylin to add stronger and more prominent warnings on the product label about the risk serious and possible Byetta side effects including acute hemorrhagic and necrotizing pancreatitis.

Byetta FDA Warning - October 2007

In October 2007, the FDA issued a health alert after it had received 30 reports of Byetta patients who developed acute pancreatitis, which is sudden inflammation of the pancreas, in Byetta users. None of those patients had hemorrhagic or necrotizing pancreatitis. Of those, 5 later suffered from kidney failure. Six patients experienced the onset or worsening of symptoms after their dosage of Byetta was increased from 5 milligrams twice daily to 10 milligrams twice daily. And according to the FDA, pancreatitis symptoms in 22 patients subsided or improved once they stopped Byetta

What is Byetta? 

Byetta is made by Amylin Pharmaceuticals Inc, and marketed jointly by Amylin and Eli Lilly, & Co. The drug was approved by the Food & Drug Administration (FDA) in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. While Byetta  may lower blood glucose levels on its own, it can also be combined with other medications such as pioglitazone, metformin, sulfonylureas, and/or insulin (not FDA approved yet) to improve glucose control. The approved use of exenatide is with either sulfonylureas, metformin and thiazolinediones. Byetta is injected subcutaneously twice per day using a pre-filled pen device.

Typical human responses to exenatide include improvements in the initial rapid release of endogenous insulin, suppression of pancreatic glucagon release, delayed gastric emptying, and reduced appetite - all of which function to lower blood glucose More than 700,000 patients worldwide have used Byetta since it was launched. While diabetics are more vulnerable to developing pancreatitis than those without the disease, it is becoming apparent that this drug increases that risk. 

ByettaŽ(exenatide), made by Amylin Pharmaceuticals, Inc., is a synthetic form of exendin-4, a 39-amino acid peptide isolated from the salivary gland venom of the Gila monster lizard (heloderma suspectum). The venom of Gila monsters has previously been found to be the cause of pancreatitis in victims of Gila monster bites due to overstimulation of the pancreas. ByettaŽ mimics the human incretin hormone, glucagon-like-peptide-1 (GLP-1), by enhancing glucose-dependent insulin secretion by the pancreatic beta-cells, suppressing elevated glucagon secretion by the liver and slowing gastric emptying. Approved by the FDA in April of 2005, ByettaŽ is indicated for use in type II diabetes as adjunctive therapy with metformin, a sulfonylurea, a thiazolidinedione or a combination of metformin and a sulfonylurea or a thiazolidinedione. Some non-diabetics have also been prescibed Byetta ( a off label use) to help in diet or wight loss as another side effect of Byetta include a reduction in appetite.

Byetta Pancreatitis Victims - Talk to a Byetta Lawyer about your Legal Rights

If you or a loved one were prescribed Byetta and have been diagnosed serious Byetta side effects including acute pancreatitis, necrotizing pancreatitis or hemorrhagic pancreatitis, then you may have a legal right to file a Byetta Pancreatitis Lawsuit. Please fill out our online form below or call us at 1-800 883-9858 to talk to a product liability / drug litigation attorney with more than 25+ years of personal injury and product liability experience.

Byetta Pancreatitis Lawsuits - Talk to a Lawyer / Attorney