Timeline of FDA Action: Byetta

Byetta is a GLP-1 agonist injection manufactured by Amylin Pharmaceuticals, Inc.  It was approved by the FDA in 2005.  Its generic name is exenatide.

Byetta is administered twice daily by injection, but also comes in a once-weekly form called Bydureon.

Byetta works by forcing the pancreas to increase insulin production and to suppress release of glucagon in response to eating.  However, it has also been associated with an increased risk of pancreatitis, and now the possibility that this class of drugs may also cause pre-cancerous changes in the pancreas is being explored.

This drug has also been linked to thyroid cancer and renal (kidney) complications and failure.

The FDA has issued many warnings and safety precautions about Byetta:

2007:  The FDA states that there seems to be an association between Byetta and pancreatitis.  The precautions section of Byetta’s label is updated to include information on this risk

2008:  More cases of pancreatitis are reported.  The FDA advises that Byetta should be stopped immediately if pancreatitis is suspected.  The warning also stated that “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.

2009:  The FDA warns that there have been reports of altered kidney function, including kidney failure.  Doctors should monitor patients carefully, especially those with a history of kidney problems, and during dosage increases

2009:  The FDA approves Byetta for a new indication.  Previously, Byetta was approved only to be used in combination with other anti-diabetic drugs.  At this time the FDA approved it for glycemic control on its own.

2013:  Byetta and other GLP-1 agonist drugs are linked not only to pancreatitis, but also to precancerous cellular change called pancreatic duct metaplasia.

Have you taken or are you taking Byetta, or any of the diabetes drugs in its class?  If you have taken one of these drugs and have suffered pancreatitis, kidney problems, or have developed pancreatic cancer, you may be entitled to compensation.  Call one of our experienced and compassionate attorneys today.  You will be able to get immediate answers and together figure out the best course of action.  Contact us today.