FDA Adds Kidney Health Warnings To Byetta Label

NEW YORK (AP) — The Food and Drug Administration approved new warnings for the diabetes drug Byetta Monday, adding cautions about links between Byetta and kidney problems.

The revised Byetta label says that Byetta should not be used by patients with kidney disease or risk factors for kidney disease because they may suffer impaired function or kidney failure. Byetta, or exenatide, is made by Amylin Pharmaceuticals Inc. and sold by Eli Lilly & Co.

The new label includes information about reports of kidney failure and insufficiency and says Byetta should not be used by patients with end-stage kidney disease or several kidney impairment. It suggests health care workers be cautious about starting patients on Byetta or increasing their doses if the patients have moderate kidney problems, or if they have had a kidney transplant.

The most common side effects included nausea, vomiting and diarrhea, and those may have contributed to the reported kidney trouble.

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