FDA Increases Warning For The Drug Byetta
The FDA stated this week that they will be increasing the warnings about the life threatening pancreas problems when connected to the drug Byetta - used for type 2 diabetes. Already two deaths have been reported as well as four hospitalizations.
Those patients had hemorrhagic pancreatitis (inflammation of the pancreas with bleeding) or necrotizing pancreatitis (in which the inflamed pancreas destroys itself). All six patients were hospitalized, and their Byetta treatment was stopped. The four survivors were still recovering at the time that the FDA learned of their illness.
Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected and not restarted if pancreatitis is confirmed, notes the FDA. Byetta, given by injection, was approved by the FDA in 2005. Last October, the FDA noted 30 reports of acute pancreatitis, which is sudden inflammation of the pancreas, in Byetta users. None of those patients had hemorrhagic or necrotizing pancreatitis.
At the time, the FDA asked Byetta’s maker, Amylin Pharmaceuticals, to include information on acute pancreatitis in the “precautions” section of Byetta’s label. Now, the FDA is working with Amylin to strengthen and draw attention to warnings about acute hemorrhagic or necrotizing pancreatitis.