Byetta® Injuries
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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).
Injections of a Relatively New Drug
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).
Acute Pancreatitis
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.
Second, Stronger Warning about Byetta® Injuries
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:
- Two died
- Four were still recovering from the pancreatitis at the time of the FDA's next alert.
If You Believe You Have Been Injured by Byetta®
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.
