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October 2009 FDA Letter About Byetta Demands That Several Safety Studies Be Done By Drug Company

FDA Wants To Know More About These Possible Byetta Side Effects: Pancreatitis, Pancreatic Cancer, Thyroid Neoplasm, And Acute Renal Failure

An October 30, 2009 letter from the FDA to Amilyn Pharmaceuticals, Inc. about Byetta lets us know that there are several serious side effects that the FDA has concerns about:

Since Byetta (exenatide) was approved on April 25, 2005, we have become aware of postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, and postmarketing reports of acute renal failure, sometimes leading to death or transplantation, in patients taking Byetta (exenatide). We have also become aware of postmarketing reports of thyroid neoplasms associated with the use of Byetta (exenatide)....

After consideration of this new safety information, we have determined that postmarketing requirements are needed to assess the risk of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, and the risk of thyroid neoplasms, and that a REMS is necessary for Byetta (exenatide) to ensure that the benefits of the drug outweigh the risks of acute pancreatitis and acute renal failure....

Therefore, based on appropriate scientific data, FDA has determined that you are required, to conduct [several studies about these possible Byetta side effects].

Byetta was recently approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Previously, Byetta was approved for use only in patients who were also taking other common diabetes medications and had not achieved adequate glycemic control.

We are investigating Byetta cases that involve serious side effects, including several types of pancreatitis -- acute, hemorrhagic, and, necrotizing pancreatitis -- as well as kidney failure and renal insufficiency requiring hospitalization.

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  • US FDA advises that you should not stop taking any prescription medication before talking to your doctor.
  • Reports of serious drug side effects should be made to the US FDA MedWatch program.
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