FDA Notes 2 Byetta Deaths

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 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.

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.