FDA calls for expanded Byetta precautions

Oct/17/2007 06:02 Filed in: Pharma Business
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Just when Byetta starts to crank up its new DTC campaign comes work of "added precautions" from the FDA. It has to do a suspected a link between usage of Byetta and acute pancreatitis. When I talked to one of my thought leaders this morning he simply stated "I am not writing any Rx's for this product until I have a better idea of what the hell is going on".


The FDA said it reviewed 30 reports of acute pancreatitis in patients taking Byetta (exenatide) and said, "An association between Byetta and acute pancreatitis is suspected in some of these cases." Officials said the maker of Byetta, Amylin Pharmaceuticals Inc and Lilly., have agreed to include information about acute pancreatitis in the precautions section of the product's label.


"Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and 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," the FDA said.


So another drug with more warnings about potential side effects. Correct me if I am wrong but the reason to write an Rx is to treat the patient and make them better? What effect this will have on the product sales is unknown at this time but judging from the buzz around Exubera on the Web and the increase in traffic to their website this author feels that Byetta sales increases might put on the breaks while Exubera sales start to see big increases in share. What is more interesting to observe is Lilly's response to this report in its communication, or lack thereof, to patients.
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