November 03, 2009
FDA warns of renal failure with ByettaThe FDA has notified healthcare professionals that the Prescribing Information for Byetta (exenatide injection, from Amylin and Lilly) has been revised to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. From April 2005 through October 2008, the FDA has received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), 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.
Healthcare providers are recommended to monitor patients for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected. Patients should be instructed to report nausea, vomiting, or dehydration, as these symptoms may contribute to altered kidney function.
Byetta, a GLP-1 receptor agonist, is indicated as monotherapy along with diet and exercise or as an adjunct to metformin, a sulfonylurea, a thiazolidinedione, or in combination with metformin and a sulfonylurea or with metformin and a thiazolidinedione to improve glycemic control in adults with type 2 diabetes.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188703.htm.