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FDA reports new cases of pancreatitis seen with Byetta
Monday, August 18 2008 | Comments
What's This?
The Food and Drug Administration has received reports of six cases of hemorrhagic or necrotizing pancreatitis in patients taking Eli Lilly and Co. and Amylin Pharmaceuticals Inc.'s type 2 diabetes drug, Byetta (exenatide), since warning health care professionals of this potential risk in October 2007. All six patients required hospitalization, the FDA said, adding that two of the patients died and four were recovering at the time of reporting. In all six cases, use of the drug was discontinued.
In the October warning, the agency said it had reviewed 30 postmarketing reports of the condition in patients treated with the drug.
If pancreatitis is suspected among patients taking the drug, Byetta should be promptly discontinued, the agency advised. No signs or symptoms are available to distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis, the FDA stated.
For patients with a history of pancreatitis, other diabetes therapies should be considered, the agency noted.
Amylin and the FDA are working together to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.
Shares of Amylin closed at $29.76, down $4.45, or 13 percent, in heavy trading on the Nasdaq.
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