Byetta
Ready to Help Whenever You Need Us
We know who to talk to, where to find answers, and what steps you need to take. Let us put our 30 years of experience to work for you.
Byetta Linked to Acute Pancreatitis
August 18, 2008—The U.S. Food and Drug Administration (FDA) has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta (exenatide), an injectable drug approved in 2005 to lower blood sugar levels in patients with Type II diabetes. Of the six cases, all patients required hospitalization and two have died, prompting the FDA to request Amylin Pharmaceutials, Inc, the drug’s manufacturer, to add stronger and more prominent warnings on the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.
Reports of Deaths despite Prior Pancreatitis Warning
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.
Signs and Symptoms of Pancreatitis
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:
Severe abdominal pain that may radiate through the back
- nausea
- vomiting
- fever
- rapid pulse
Acute hemorrhagic (inflammation of the pancreas with bleeding), or necrotizing (inflammation causing tissue death) pancreatitis are severe forms of pancreatitis that can lead to the release of toxins into the blood stream risking damage to other organs. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis with Byetta from the less severe form of pancreatitis. 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 an alternative etiology is identified.
If you or your loved one has suffered a Byetta injury, contact us today. Submit the form to the right and we’ll let you know if you have a case and if we can represent you.