Diabetes Drug Byetta Is Related To Pancreatitis And Deaths, Says FDA

Byetta® (exenatide) was associated with at least 6 cases of hemorrhagic or necrotizing pancreatitis (a severe inflamation of the pancreas) reported to FDA since the drug last came under regulatory scrutiny according to a disclosure released by the FDA on August 18, 2008.   Two of the patients reportedly died.

Breaking News - First Byetta Lawsuit Filed: Moore Labriola LLP and The Schmidt Firm, LLP represent Virginia man who developed pancreatitis FDA seeks more stringent warnings

In the fall of 2007, manufacturer Amylin Pharmaceuticals, Inc. added precautionary language to the label for the drug after FDA reported on 30 cases of pancreatitis associated with the injectable medication.  This followed reports of similar cases published in the medical literature.   

It now appears that the labeling for the drug was inadequate to effectively reduce the risk.  FDA says it is now “working with” Amylin “to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.”

http://www.fda.gov/Cder/drug/InfoSheets/HCP/exenatide2008HCP.htm. 

Questions have now been raised as to why Amylin did not adequately warn about the pancreatitis risk earlier.  Drug manufacturers often “negotiate” with the FDA over changes to drug labeling, especially when the Agency indicates a desire to place a “warning” about certain potential side effects on written information distributed by companies to prescribing doctors.  

In the case of Byetta®, information about pancreatitis is currently contained in a “precautions” section of the label instead of a “warning.”  That will apparently change, according to FDA, but changes in the label will come too late for those who developed derious cases of pancreatitis.       

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