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Byetta FDA Warning & Approval Information

Byetta FDA Warning & Approval Information

The FDA approved Byetta (exenatide) in 2005. Since then, the agency has published numerous warnings after hundreds of patients suffered from pancreatitis, kidney failure, pancreatic cancer, thyroid cancer, and other side effects.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Byetta induced injury cases in all 50 states. If you or somebody you know was diagnosed with pancreatic cancer or thyroid cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

FDA Approves Byetta

Byetta (exenatide) was approved by the FDA on April 28, 2005. It was the first FDA-approved diabetes drug in a new class called glucagon-like peptide-1 (GLP-1) agonists.

Between 2005 and 2009, more than 7 million Byetta prescriptions were written. As with many new medications, Byetta was soon linked to several unanticipated side effects during this time.

FDA Warnings for Byetta

Pancreatitis Safety Warning

The FDA has published two safety warnings about pancreatitis from Byetta. From 2005-2007, the FDA received 30 reports of acute pancreatitis (sudden inflammation of the pancreas). Most patients required hospitalization. The warning was updated in August 2008 after the FDA received 6 additional reports of hemorrhagic or necrotizing pancreatitis. These life-threatening forms of pancreatitis occur when the pancreas bleeds and causes tissue death.

Kidney Failure Warning

The FDA warned about the risk of kidney failure in November 2009, after they received 78 reports of the altered kidney function between April 2005 and October 2008. More than 90% of individuals required hospitalization, there were 62 reports of acute kidney failure, 16 reports of renal insufficiency (decreased kidney functioning), and 4 deaths. All of the individuals stopped taking Byetta, but only 39 (50%) recovered.

Pancreatic Cancer Warning

In a 2009 Safety Update for Healthcare Providers, the FDA announced that they would require Amylin Pharmaceuticals to investigate the risk of pancreatic cancer and thyroid cancer by conducting six studies. In 2011, study in Gastroenterology linked Byetta with dozens of cases of cancer.

In March 2013, the FDA issued a Safety Communication after researchers at UCLA found evidence of pre-cancerous growths in the pancreases of patients who used Byetta. However, the FDA did not update the label.

Researchers autopsied pancreases and found evidence of excessive and unusual cell proliferation, especially around the pancreatic duct, which is where most pancreatic cancers start. They also found microadenomas, with are small tumors that can become malignant and cause pancreatic cancer.

The study is found here:

Marked Expansion of Exocrine and Endocrine Pancreas with Incretin Therapy in Humans with increased Exocrine Pancreas Dysplasia and the potential for Glucagon-producing Neuroendocrine Tumors. Alexandra E Butler et al. Published online before print March 22, 2013, doi: 10.2337/db12-1686. Diabetes March 22, 2013

Do I have a Byetta Lawsuit?

The Schmidt Firm, PLLC is currently accepting Byetta induced injury cases in all 50 states. If you or somebody you know was diagnosed with pancreatic cancer or thyroid cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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