The FDA ( Food and Drug Administration ) has completed a review of 78 cases of altered kidney function reported in patients with diabetes using Byetta ( Exenatide ). The cases were reported to FDA’s Adverse Event Reporting System ( AERS ) between April 28, 2005 and October 29, 2008. Sixty-two of the cases were classified as acute renal failure and 16 cases were classified as renal insufficiency. Cases of acute renal failure or insufficiency occurred as soon as 3 days and up to 2 years after initiation of Byetta. The patient ages ranged from 23 to 83 years, with an average age of 60 years.

The majority of patients, 74/78 ( 95% ), had at least one contributory risk factor for altered kidney function, such as cardiac insufficiency, hypertension, pancreatitis, rhabdomyolysis, and urinary tract infection, as well as concomitant medications such as antiretrovirals, antihypertensives, diuretics, and non-steroidal anti-inflammatory drugs ( NSAIDs ). These factors could independently increase the risk for developing altered kidney function. Forty-two patients ( 54% ) reported symptoms associated with volume depletion, such as diarrhea, and/or vomiting, which are also known risk factors for altered kidney function and are the most commonly reported adverse events associated with the use of Byetta.

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. Of those patients who required dialysis, six had no prior history of altered kidney function, two had a prior history of altered kidney function, and the remaining 10 patients reported no information regarding prior renal history.

Byetta was discontinued in 63 of 78 ( 80% ) patients, with 39 ( 50% ) patients reporting improved signs and symptoms after discontinuation of the drug. One patient experienced recurrent altered kidney function after re-initiation of Byetta.

Notably, 14 of the cases had past medical histories of chronic kidney disease, including four with chronic renal failure, despite recommendations against the use of Byetta in these patients in the current prescribing information.

Due to the serious potential consequences of altered kidney function and temporal relationship between the development of renal effects and initiation of Byetta, FDA has approved revisions to the drug label for Byetta to describe this risk.

Source: FDA, 2009

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