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Diabetes Drug Label to Address Safety Concerns: FDA

 
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A drug used to treat type 2 diabetes, Byetta, may contribute to kidney malfunction, the U.S. Food and Drug Administration warned Monday as it moved to revise safety information on the label.

Over a three-year period, the FDA received 78 reports of kidney problems, including kidney failure, among patients using Byetta, it said in a statement. Some of the patients had pre-existing kidney disease, while others were at risk of developing kidney disease.

"Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems," said Dr. Amy Egan, of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research. "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."

Patients with any of these symptoms should notify their physician right away.

Because of the safety concerns, the FDA is working with drug make Eli Lilly and Co. to update prescribing information on the label.

Altered kidney function, which causes waste products to build up in the blood, can lead to serious or life-threatening conditions.

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