(RTTNews) - 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: News ) 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.

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