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Byetta Gets New Warning About Severe Kidney Side Effects, Including Acute Renal Failure

November 2009 Byetta Label Change Follows Numerous Reports Of Kidney Problems By Patients Using This Diabetes Drug

The FDA announced in early November 2009 that it had approved revisions to the Byetta package insert, or label, so that it will now include information about numerous case reports of kidney-related side effects, including kidney failure and renal insufficiency.

According to the FDA, 62 cases of acute kidney failure and 16 cases of renal insufficiency in patients using Byetta (exenatide) had been reported to the agency from April 2005 – when this diabetes medication was first approved for sale in the U.S. – through October 2008.

A document issued by the FDA on November 2, 2009, Information for Healthcare Professionals: Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta), makes clear the severity of these kidney-related side effects:

Hospitalization was required in 71 of 78 (91%) patients and there were 4 deaths reported in the cases reviewed. Eighteen patients required dialysis and two patients required kidney transplantation after initiation of Byetta.

For more information from the relevant drug companies about this Byetta label change concerning the potential for altered renal function and other serious kidney-related side effects, we direct you to the following resources:

In the U.S. Byetta is co-marketed by Amylin and Eli Lilly.

Turning to other Byetta drug side effects: In October 2007 the FDA issued an alert to inform doctors that 30 reports of acute pancreatitis in patients taking Byetta had been received by the agency since April 2005; and, in August 2008 the FDA issued an alert to inform doctors about six cases of hemorrhagic pancreatitis or necrotizing pancreatitis that had been reported to FDA since October 2007.

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Read more on our Byetta Information Page >>


  • 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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