Byetta Safety Label Revised


Today the FDA indicated that the safety label of Byetta would be modified to include potential kidney problems including possible kidney failure. According to the FDA website “From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function in patients using Byetta.” Seven million Byetta prescriptions were issued during this time, so this represents about 1 in 100,000 people being affected.

Byetta is a drug taken to assist in the processing of blood sugar. It is one of a family of drugs known as incretin based therapies.   One of the side effects of Byetta, as well as other incretin based therapies, is vomiting. This is thought to play a role in kidney dysfunction.

In February, Diabetes Care published a short report on 4 patients who had suffered serious kidney damage from Byetta therapy, and this may serve as an example of what has happened to the others. All four patients presented with vomiting and decreased fluid intake. Because of their diabetes induced hypertension, they took ACE inhibitors and diuretics. All suffered kidney failure within 2 – 9 months of initiating Byetta therapy and were taken off the treatment upon diagnosis. All recovered some kidney function although recovery was not complete in 3 out of the 4 patients.

The opinion of the authors was that the combination of vomiting (fluid loss), decreased fluid intake, ACE inhibitors, and diuretics created too much of a stress for the kidneys. They did point to a study which shows that the incretin GLP-1 was shown to perhaps decrease kidney function in healthy subjects, however it is not known if Byetta does this or not.

If you have kidney problems you may not want to take Byetta. If you do take Byetta, be sure to keep your fluid levels up by drinking sufficient amounts of water. As with all therapies, consult with your doctor before making any changes.

By: Robert Scheinman

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