Exenatide (marketed as Byetta) Information

FDA ALERT [10/2007]:  FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, a drug used to treat adults with type 2 diabetes.  An association between Byetta and acute pancreatitis is suspected in some of these cases. 

Healthcare professionals should 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.

FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label. 

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA is not advising practitioners to discontinue prescribing the product.  FDA intends to update this sheet when additional information or analyses become available. 

To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program and complete a form on line at http://www.fda.gov/medwatch/report/hcp.htm or report by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.  

Healthcare Professional Information

• Information for Healthcare Professionals (10/16/2007)
• Labeling for Exenatide from Drugs@FDA

Patient Information

• Patient Information Sheet (5/2005)
  

Report Adverse Events to MedWatch

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Date created: October 16, 2007, updated February 14, 2008

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