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Byetta (exenatide), an injectible drug approved in 2005 to lower blood sugar levels in patients with Type II diabetes, has been linked with a severe form of pancreatitis. Due to the severity of the cases, the FDA has requested that Amylin Pharmaceuticals, Inc - the drug's manufacturer - add stronger and more prominent warnings on the product label about the risk of acute and severe pancreatitis.
The call for stronger warnings comes just ten months after the FDA issued an earlier Safety Alert warning of the risk of acute pancreatitis associated with Byetta and requesting information about acute pancreatitis be added to the product labeling. The October 2007 Safety Alert followed the FDA's review of 30 post-marketing reports of acute pancreatitis in patients taking Byetta. Twenty-one of those patients were hospitalized and five patients developed serious complications and renal failure. In six of the reported cases, the symptoms began or worsened soon after the dose of Byetta was increased from 5 mcg twice daily to 10 mcg twice daily.
The FDA has advised healthcare professionals 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. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless the case is deemed unrelated.
Pancreatitis is the inflammation of the pancreas, a gland that secretes enzymes into the small intestine to aid in digesting fats, proteins and carbohydrates in food, and releases insulin into the bloodstream to help the body convert glucose from food into energy. Symptoms of pancreatitis may include:
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