The FDA today said it plans to strengthen warnings about life-threatening pancreas problems linked to the type 2 diabetes drug Byetta after getting two reports of deaths and four other hospitalizations in Byetta users.
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.
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