On August 18, 2008 the U.S. Food & Drug Administration issued an URGENT NATIONWIDE WARNING regarding Byetta, a drug used to treat adults with type 2 diabetes.
Byetta has been linked to over 30 cases of acute pancreatitis. Recently, the FDA has received an additional 6 reports of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.
What is Byetta?
Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. The drug is manufactured by Amylin Pharmaceuticals, Inc.
FDA Byetta Information
The Byetta full prescribing information will include new information in the PRECAUTIONS section about the potential for acute pancreatitis in patients taking Byetta.
Recommendations and Considerations
- Healthcare providers should be alert to the signs and symptoms of acute pancreatitis. Symptoms include persistent severe abdominal pain that can radiate to the back and may be accompanied by nausea and vomiting. Acute pancreatitis is typically confirmed by the presence of elevated levels of serum amylase and/or lipase and characteristic findings by radiological imaging.
- Discontinue Byetta if pancreatitis is suspected. If pancreatitis is confirmed, do not restart Byetta unless an alternative etiology for the pancreatitis is identified.
Information for the patient: Physicians who prescribe Byetta should discuss with their patients:
Byetta is a medicine given by injection to help treat adults with type 2 diabetes. Commonly reported side effects of Byetta include nausea, vomiting, diarrhea, indigestion and upper abdominal discomfort. However, the presence of unexplained, severe abdominal pain, with or without nausea and vomiting, raises the suspicion of acute pancreatitis, a potentially serious condition that requires prompt medical attention. Therefore, patients taking Byetta should promptly seek medical care if they experience unexplained severe abdominal pain with or without nausea and vomiting.
Do I Have a Lawsuit?
If you or a loved one have developed pancreatitis or died while taking Byetta, you should contact us immediately. Schmidt & Clark, LLP is current accepting Byetta side effect cases in all 50 states. You may contact us directly for a free confidential case evaluation by using the form below or calling toll free 24 hrs/day (866) 879-3040.
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