Safety Alerts & Recalls

What does this mean?

Decreased kidney function and acute kidney failure are serious conditions. Although kidney problems have been reported in only a small percentage of patients who have used Byetta, patients who use Byetta should be aware of this possible risk. Make sure to drink enough water and other fluids to avoid dehydration, particularly when exercising, in hot weather, or when you have nausea, vomiting or diarrhea.

If you are using Byetta and you have a history of kidney problems, talk to your doctor about your risks for worsening kidney function with Byetta treatment - you and your doctor may want to consider other antidiabetic therapies.

All patients who use Byetta should pay close attention for any signs or symptoms of altered kidney function, such as changes in urination (color, frequency, amount), unexplained swelling in your arms or legs, changes in blood pressure, lethargy or tiredness, changes in appetite or digestion, or a dull ache in the mid to lower back. Nausea, vomiting, diarrhea, or dehydration while using Byetta may increase your chances of developing decreased kidney function. If any of these side effects occur, please contact your doctor or other health care professional as soon as possible.

You may also wish to review the Byetta Medication Guide and follow up with your doctor if you have any questions or concerns. Do not stop or change medicines that been prescribed without first talking with your doctor. The Byetta Medication Guide can be found here: http://pi.lilly.com/us/byetta-ppi.pdf

Reports of Altered Kidney Function in Patients Using Byetta

The FDA has approved revisions to the prescribing information for Byetta (exenatide) to include information about post-marketing reports of decreased kidney function, including cases of acute renal failure where the kidneys suddenly stop working. Some of the cases have been associated with dehydration from nausea, vomiting, and diarrhea, which are known side effects of Byetta. These reported cases of altered kidney function have occurred in a very small percentage of the total number of patients who have used Byetta.

Byetta is a medicine given by subcutaneous injection for the treatment of Type 2 Diabetes.

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Source: FDA
Publication Date: 2009-11-03
Last Updated: 2009-12-05

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