Monday, September 01, 2008

Byetta Under More Scrutiny After Deaths

The injectable diabetes drug exenatide (marketed as Byetta, by Amylin Pharmaceuticals and Eli Lilly) was launched in 2005.

In 2007, the FDA issued an alert warning of a possible association between Byetta and acute pancreatitis, after 30 reports of the condition surfaced. Pursuant to that warning:
"FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label." 1
That was in October of last year. This August, the FDA said they received 6 more reports of "hemorrhagic or necrotizing pancreatitis in patients taking Byetta." Two of those patients died. (The Wall Street Journal is reporting that Amylin and Eli Lilly told the FDA of 4 additional deaths.)

Pursuant to those reports:
"FDA is working with the maker of Byetta, Amylin Pharmaceuticals, Inc., to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis." 1
The FDA is strongly advising that patients stop taking Byetta immediately if they develop signs or symptoms of acute pancreatitis.

The NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) lists the following symptoms for acute pancreatitis:
  • Symptoms can arise suddenly
  • Pain in the upper abdomen, may be severe or begin as mild discomfort that worsens after eating
  • Pain may radiate to the back and other areas
  • Abdomen may swell and become tender
  • Pain may be associated with nausea and vomiting
  • Fever
  • Rapid pulse
  • Breathing problems

1 FDA: Information for Healthcare Professionals, Exenatide (marketed as Byetta)