The United States Food and Drug Administration (FDA) asked Amylin Pharmaceuticals to change its type 2 diabetes drug’s label to include a warning of acute pancreatitis. The recommendation comes after the agency received 30 reports of the illness in patients taking the drug, Byetta.

Twenty-one patients were hospitalized, five of whom developed serious complications of pancreatitis, such as dehydration and renal failure. Pancreatitis symptoms in six patients began or worsened soon after their dose of Byetta was doubled. Details from three patients indicated the symptoms of pancreatitis returned when Byetta was restarted.

In some of these cases, the FDA said, this evidence suggests an association between Byetta and acute pancreatitis. The agency recommended doctors instruct patients who are taking Byetta to seek medical care if they have unexplained persistent abdominal pain, possibly accompanied by vomiting. If doctors suspect a patient is showing symptoms of pancreatitis, they should discontinue the drug.

Source: Peggy Peck, “FDA wants pancreatitis caution added to exenatide (Byetta) label,” MedPage Today, October 16, 2007.