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There have been a number of complaints regarding Byetta® made to the U.S. Food and Drug Administration (FDA). For instance, some people say they believe use of Byetta® may be linked to a development hemorrhagic pancreatitis, a sudden and debilitating inflammation of the pancreas (a comma-shaped organ sitting just behind the stomach that produces digestive enzymes, insulin and glucagon, which are crucial to the body's use of sugar, fat and protein).
About one million diabetics in the U.S. take Byetta®, a very successful and effective treatment for Type 2 diabetes. Byetta® is provided in the form of a "pen" that gives subcutaneous injections of exenatide, a new, synthetic drug. Byetta® injuries may be due in part or entirely to the effects of exenatide, which doesn't have a long safety record (it was approved by the FDA in 2005 for the treatment of diabetes mellitus type 2).
The FDA has required several revisions of Byetta's® prescribing information in order to warn physicians and patients of the risks of Byetta® injuries. In late 2007, the FDA's safety alert described its review of 30 cases of acute pancreatitis among Byetta® users. The alert stated that a link between Byetta® and pancreatitis was suspected, and the FDA recommended that Byetta's® packaging information be revised to include the information about pancreatitis.
Reports of possible injurries from the Byetta® drug continued to be sent to the FDA, and by the fall of 2008, the FDA had received six more reports of necrotizing or hemorrhagic pancreatitis in Byetta® patients. Of those six patients:
If you or a loved one believes to have been injured after taking Byetta®, contact us to speak with an experienced Byetta® attorney who will evaluate the details of your circumstances to determine if you have a case.