FDA: Byetta Label Revised to Include Safety Information on Possible Kidney Problems

FDA: Byetta Label Revised to Include Safety Information on Possible Kidney
Problems

SILVER SPRING, Md., Nov. 2 /PRNewswire-USNewswire/ -- The U.S. Food and Drug
Administration today acted on new safety information about possible kidney
function problems, including kidney failure, in patients taking Byetta
(exenatide), a drug used to treat Type 2 diabetes.

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From April 2005 through October 2008, the FDA received 78 reports of problems
with kidney function in patients using Byetta. Some cases occurred in patients
with pre-existing kidney disease or in patients with one or more risk factors
for developing kidney problems.

Nearly 7 million prescriptions for Byetta were dispensed between April 2005
and September 2008. The 78 cases represent a small percentage of the total
number of patients using the drug to control blood sugar (glucose) levels.

The most common side effects associated with Byetta include nausea, vomiting,
and diarrhea. These side effects may have contributed to the development of
altered kidney function. Kidney malfunction can result in a build-up of waste
products in the blood, leading to serious illness or life-threatening
conditions.

"Health care professionals and patients taking Byetta should pay close
attention to any signs or symptoms of kidney problems," said Amy Egan, M.D.
M.P.H., 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 who experience any of these symptoms should immediately discuss them
with their health care professional.

To help health care professionals and patients better weigh the known risks
and benefits of Byetta, the FDA worked with the manufacturer to update the
drug's prescribing information (label). A description of these label changes
can be found online at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm188656.htmhttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113705.htm

Byetta is manufactured by San Diego-based Amylin Pharmaceuticals Inc.

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Media Inquiries: Sandy Walsh, +1-301-796-4669, sandy.walsh@fda.hhs.gov