Kidney Injury Risks Behind Label Change for Type 2 Diabetes Drug Byetta
Labeling on the type 2 diabetes drug Byetta has been changed to include the risk of kidney functioning problems, the Food and Drug Administration said.
Byetta, known chemically as exenatide, is made by San Diego-based Amylin Pharmaceuticals Inc. It has been linked to 78 reports of kidney function injury from April 2005 to October 2008. Some of those patients already had underlying kidney disease or other factors that put them at increased risk of kidney problems, the FDA said in a notice posted today on the agency’s website.
Diabetics taking Byetta also have suffered a painful injury called hemorrhagic pancreatitis (also called inflammation of the pancreas). The Food and Drug Administration has repeatedly warned about Byetta’s connection to pancreatic disease and warned users about the risk.
FDA Urges Caution With Byetta
With nearly seven million Byetta prescriptions dispensed from April 2005 through September 2008, the FDA said the 78 cases “represent a small percentage of the total number of patients using the drug to control blood sugar (glucose) levels.”
Still, the agency is advising doctors and patients to “pay close attention to any signs or symptoms of kidney problems” in patients taking Byetta.
“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,” 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.
Other common side effects of Byetta include vomiting, diarrhea, and nausea, which may contribute to the development of reduced kidney functioning, according to the FDA.
“Kidney malfunction can result in a build-up of waste products in the blood, leading to serious illness or life-threatening conditions,” the FDA said in a statement.
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