FDA Notes 2 Byetta Deaths
FDA Receives 2 Reports of Death, 4 More Hospitalizations in Patients Using Type 2 Diabetes Drug Byetta
Aug. 18, 2008 -- 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
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
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.
Amylin and the drug company Eli Lilly and Company collaborate on Byetta.
Amylin spokeswoman Anne Erickson emailed a joint statement from Amylin and
Lilly to WebMD.
The companies state that pancreatitis is rare in the general public but more
common among type 2 diabetes patients.
In patients using Byetta, there have been "rare" case reports of
pancreatitis and "very rare" case reports of pancreatitis with
complications or fatalities, and the proportion of complicated or fatal cases
is "similar" to that observed in the general public with pancreatitis,
according to Amylin and Lilly.