Byetta Diabetes Drug Side Effects linked to Pancreatitis & 2 Deaths

Updated Aug. 27 - Four more deaths were reported yesterday by people who'd been taking the medication Byetta.

The announcement by Eli Lilly and Amylin Pharmaceuticals Inc. came a week after the U.S. Food and Drug Administration said that two Byetta users had died of acute pancreatitis, a condition that can cause nausea, vomiting and abdominal pain.

Lilly's medical director, James Malone, said Tuesday that the FDA was aware of the four additional deaths last week, but did not make them public because they involved a milder form of pancreatitis, the Associated Press reported. .

The FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta.

Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

The FDA warned patients taking Byetta, marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., to discontinue use if they develop symptoms of the disorder and said doctors should consider other prescription options for patients with a history of pancreas problems.

Information from Wikipedia

Exenatide (marketed as Byetta) is the first of a new class of medications (incretin mimetics) approved for the treatment of type 2 diabetes. It is manufactured and marketed by Amylin Pharmaceuticals and Eli Lilly and Company. Exenatide is a synthetic version of exendin-4, a hormone in the saliva of the Gila monster, a lizard native to several Southwestern American states. It displays properties similar to human GLP-1.

Exenatide is a 39-amino-acid peptide that mimics the GLP-1 incretin, an insulin secretagogue with glucoregulatory effects. While it 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. The medication 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. Whereas some other classes of diabetes drugs such as sulfonylureas, thiazolinediones, and insulin are often associated with weight gain, Byetta often is associated with significant weight loss.

Unlike sulfonylureas and meglitinides, exenatide increases insulin synthesis and secretion in the presence of glucose only, lessening the risk of hypoglycemia. Byetta is also being used by some physicians to treat insulin resistance.

In October 2007 the FDA issued a warning and said it had reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta . An association between Byetta and acute pancreatitis was suspected in some of those cases. Amylin Pharmaceuticals, Inc. agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.

Healthcare professionals were to be alert to the signs and symptoms of acute pancreatitis and told to instruct patients taking Byetta to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting.