FDA Warns of Potential Link Between Byetta and Pancreatitis

Yael Waknine

October 17, 2007 — Use of exenatide (Byetta, Amylin Pharmaceuticals, Inc) may be linked to a risk for pancreatitis, the US Food and Drug Administration warned healthcare professionals yesterday.
The warning was based on data from 30 postmarketing reports of acute pancreatitis in exenatide-treated patients, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.
Most of the patients had at least 1 additional risk factor for the condition, such as gallstones, severe hypertriglyceridemia, and alcohol use. Less often (7 cases), the advent of pancreatitis symptoms corresponded with increases in twice-daily dosing from 5 to 10 µg.
Of 21 patients requiring hospitalization, 5 developed serious complications that included dehydration and renal failure, suspected ileus, phlegmon, and ascites. No cases of hemorrhagic or necrotizing pancreatitis were reported.
Although the role of exenatide remains unclear, 22 patients (73%) improved after discontinuation of therapy. Details from 3 reports showed that symptoms of pancreatitis returned with resumption of therapy — 2 patients experienced nausea and vomiting, and a third developed abdominal pain that abated upon permanent discontinuation of exenatide.
Healthcare professionals are advised to remain alert for signs and symptoms of acute pancreatitis and to instruct patients to seek prompt medical care for unexplained, persistent abdominal pain with or without vomiting.
Treatment with exenatide should be discontinued if pancreatitis is suspected and permanently discontinued upon diagnostic confirmation (elevated serum amylase and/or lipase levels and radiologic imaging) unless another etiology is identified.
Exenatide is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who have not achieved adequate control with metformin, a sulfonylurea, a thiazolidinedione, or a combination of these.