Monday, the U.S. Food and Drug Administration said it approved revisions to the drug label for Byetta to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta or exenatide is a drug used to treat Type 2 diabetes and is manufactured and marketed by Amylin Pharmaceuticals, Inc., (AMLN) and Eli Lilly and Company (LLY).
The FDA said that it received 78 reports of problems with kidney function in patients using Byetta from April 2005 through October 2008. Nearly 7 million prescriptions for Byetta were dispensed between this period and the 78 cases represent a small percentage of the total number of patients using the drug to control blood sugar levels. It added that some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems.
According to the FDA, 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," she added.
FDA's updated label expands indication for the drug as a stand-alone medication along with diet and exercise to improve glycemic control in adults with type 2 diabetes.
The FDA also approved changes to the Byetta Prescribing information to add updated safety information regarding the drug's use in patients with renal impairment, which Amylin and Lilly updated in September 2007 to include additional language regarding renal adverse events.
In response to the FDA update on Byetta, Amylin Pharmaceuticals and Eli Lilly in a statement said that the "update issued today aligns with the Byetta label approved last week" and that information about use of Byetta in patients with impaired renal function was included in the initial product label in 2005 and was updated in 2007.
The two companies said that their update specifies that Byetta should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with renal transplantation. It also specifies that because the drug may induce nausea and vomiting with low blood volume, treatment may worsen renal function.
Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals said, "The current label reflects our understanding of post-marketing reports of renal events and provides physicians with updated guidance about appropriate use in patients with renal conditions. There is no evidence from preclinical and clinical studies that Byetta has any direct toxic effect on the kidney."
Kolterman added that it is important to note that diabetes is the leading cause of kidney failure and post-marketing reports of serious changes in renal function have been rare and usually complicated by other factors that could have contributed to the kidney problems.
The drug Byetta is indicated with an extensive post-marketing experience and a well-documented safety profile, having been used by more than one million patients since market introduction in 2005. Amylin and Eli Lily said the drug has a proven history with more than 10 million prescriptions written and 6.5 years of clinical experience.
AMLN closed Monday's last trade on the Nasdaq at $12.12, up $1.08 or 9.78%.
LLY closed Monday's last trade on the New York Stock Exchange at $34.05, up $0.04 or 0.12%.
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