Byetta Linked to Acute Pancreatitis
Yael Waknine
August 18, 2008 — Six new cases of hemorrhagic or necrotizing
pancreatitis have been reported in patients using exenatide
injection (Byetta, Amylin Pharmaceuticals,
Inc), the US Food and Drug Administration (FDA)
advised healthcare professionals today. All 6 cases have required hospitalization, and 2 patients have died,
according to an alert issued by MedWatch, the FDA's safety information and adverse event reporting
program. Four patients were recovering at the time of reporting; all had
discontinued exenatide therapy. As a result of these and previously reported cases of pancreatitis,
the FDA has asked the manufacturer to include
information regarding acute pancreatitis in the precautions section of the
safety labeling for exenatide.
Because there are no signs or symptoms that distinguish acute exenatide-related hemorrhagic or necrotizing pancreatitis
from less severe forms of the condition, clinicians are advised to promptly
discontinue exenatide and other potentially causal
drugs if pancreatitis is suspected. Patients should be informed that
persistent abdominal pain, which may be accompanied by vomiting, is the
hallmark symptom of acute pancreatitis. If pancreatitis is confirmed, the condition should be treated
appropriately and the patient carefully monitored until recovery. Exenatide therapy should not be resumed, and other antidiabetic therapies should be considered in patients
with a history of pancreatitis. 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 drugs. Adverse events related to use of exenatide
should be reported to the FDA's MedWatch
reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178,
online at http://www.fda.gov/medwatch,
or by mail to |