FDA Updates Alert For Exenatide

According to the FDA, within the last year, six cases of hemorrhagic or necrotizing pancreatitis have been reported in patients taking exenatide for type 2 diabetes.

In October of 2007, the FDA issued an alert for health care professionals after reviewing postmarketing reports for exenatide (Byetta, Amylin Pharmaceuticals Inc.), which revealed 30 cases of pancreatitis linked to the drug.
Of the six cases mentioned in the updated alert, all required hospitalization, two died and four were recovering at the time the report was made.

The FDA urged health care professionals to discontinue exenatide in patients who present with signs or symptoms of pancreatitis. Once pancreatitis is confirmed in these patients, the FDA recommended appropriate treatment and monitoring until recovery.

The FDA recommended against the re-initiation of exenatide following recovery, but instead suggests alternative antidiabetic therapies.

In addition to the already-present pancreatitis warning in the “precautions” section of the product labeling information, the FDA is working with the pharmaceutical company to develop more prominent warnings.

Steven Edelman, a doctor and professor of endocrinology, diabetes and metabolism internal medicine at the University of California San Diego Medical School,  commented that,  “People who are type 2 diabetics have a high triglyceride level, a leading cause of pancreatitis.” Edelman further suggested that data from Byetta’s clinical trial may even support the theory that it might prevent pancreatitis: of thousands of people who took Byetta in the clinical trial, three developed pancreatitis while six people taking a placebo developed pancreatitis.  “However, I think it is super important that the company and FDA monitor this thing closely to be sure,” Edelman said.   Edelman said he has prescribed Byetta to hundreds of patients. Its advantage over other drugs is that it helps patients lose weight, he said. Other type 2 diabetes medications make patients gain weight, a problem in a disease linked to obesity.