UPDATE: FDA considering strong warning on Byetta; potential fall-out for all GLP-1s
The US Food and Drug Administration is considering strengthening the label for diabetes drug Byetta (exenatide), calling into question the entire class of GLP-1 analogs, as the number of deaths among patients on the drug rose to six from two a week earlier.
The agency could go as far as to put a black box warning on the twice-daily injection for type 2 diabetes, which is made by the USA's Amylin Pharmaceuticals and drug major Eli Lilly, after patients developed pancreatitis.
Last year (Marketletter October 22, 2007), the FDA issued a letter warning about Byetta's pancreatitis risk, after it received 30 reports of patients developing acute cases of inflammation of the pancreas, 27 of whom were hospitalized.
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