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Byetta Linked to Pancreatitis and Kidney Failure

Byetta (exenatide) is an injectable drug that works by helping to reduce blood sugar levels in patients with type 2 diabetes. It was approved by the FDA in April 2005 and has since been prescribed to more than 7 million Americans.

Since its initial approval, the FDA has issued three separate safety communications warning of potentially fatal adverse events associated with Byetta:

  • 2007 (acute pancreatitis)
  • 2008 (hemorrhagic and necrotizing pancreatitis)
  • 2009 (altered kidney function)


In 2007, the FDA issued a Safety Alert warning patients about the risk of pancreatitis linked to Byetta. In 2008, the FDA updated the alert with reports of 6 patients experiencing hemorrhagic and necrotizing pancreatitis. All 6 cases required patient hospitalization- two of these patients died. Symptoms of pancreatitis include:

  • Nausea
  • Vomiting
  • Fever
  • Rapid Pulse


In November 2009, the FDA announced that new prescribing information would be added to Byetta, including reports of side-effects linked to kidney and renal failure. At that time, the agency indicated that at least 78 reports had been received of Byetta users experiencing altered kidney function, including at least 62 reports of kidney failure. Symptoms of kidney failure include:

  • Fatigue
  • Unexplained swelling of the hands or feet
  • Dull ache in the mid-to-low back
  • Changes in appetite or digestion
  • Changes in urine color
  • Changes in frequency of urination or the amount of urine


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