FDA Warns Exenatide Could Cause Kidney Problems

New label has safety information; some patients with problems had pre-existing conditions

TUESDAY, Nov. 3 (HealthDay News) -- The U.S. Food and Drug Administration has revised the label of the type 2 diabetes drug exenatide (Byetta) to provide information about possible kidney function problems, including kidney failure, according to a Nov. 2 press release issued by the agency.

The agency made the changes based on 78 reports of kidney function problems in patients taking Byetta between April 2005 and October 2008. The most common side effects associated with the drug are nausea, diarrhea and vomiting, and it's possible that they contributed to the development of kidney function problems.

The release stated that, from April 2005 to September 2008, nearly seven million Byetta prescriptions were dispensed, so the 78 cases make up a tiny percentage of the patients taking the drug. In addition, some of the patients who reported kidney function problems had pre-existing kidney disease or one or more risk factors for developing kidney problems.

"Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems," Amy Egan, M.D., of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement. "Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back."

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