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The FDA announced Monday that new labeling information will be added to the diabetes drug Byetta about reports of users who developed kidney failure and other renal problems.
The agency indicates that at least 78 post-marketing reports have linked Byetta side effects to altered kidney function, including 62 reports of kidney failure.
The new labeling warns healthcare professionals to watch for signs of Byetta kidney problems, especially when starting treatment or increasing dosage in patients with moderate pre-existing kidney problems. The FDA indicates that some of the patients who reported Byetta kidney side effects had pre-existing kidney disease or increased risk factors for problems. The new labeling will also highlight that the drug should not be used in patients with severe renal impairment or end-stage kidney disease.
Byetta (exenatide) is a type 2 diabetes drug that is used to control blood sugar levels. It is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels. Byetta is manufactured by Amylin Pharmaceuticals and Eli Lilly & Co. The FDA reports that nearly 7 million prescriptions for Byetta were issued from April 2005 through September 2008.
The FDA indicates that the most common side effects from Byetta include nausea, vomiting and diarrhea, which could be a contributing factor to altered kidney function. Kidney failure on Byetta can lead to a build-up of waste products in the blood, which can result in serious illness or death.
“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.”
In October 2007 and August 2008, the FDA issued a safety alerts about reports that linked Byetta side effects to pancreatitis, including severe cases of hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal. Symptoms of pancreatitis, which is an inflammation of the pancreas, include nausea, vomiting, severe pain in the upper abdomen and back, a rise or fall in blood pressure, and increased heart or respiratory rates.