FDA: Byetta drug label is revised

WASHINGTON, Nov. 2 (UPI) -- The U.S. Food and Drug Administration says it has approved a Byetta drug label revision to include information about possible kidney function problems.

Byetta (exenatide) is a drug used to treat Type 2 diabetes.

The FDA said it received 78 reports between April 2005 through October 2008 about kidney problems in patients taking Byetta.

The most common side effects associated with Byetta include nausea, vomiting, and diarrhea, but the FDA said those side effects might have contributed to the development of altered kidney function.

"Healthcare professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems," said Dr. Amy Egan of 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 experiencing any of those symptoms should immediately discuss them with their health care professional.

A description of the label changes can be found at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm188656.htm.

Byetta is manufactured by Amylin Pharmaceuticals Inc. of San Diego.