CORRECT:=FDA Approves New Byetta Label Amid Renal-Failure Reports

The U.S. Food and Drug Administration on Monday said it approved a new label for the diabetes treatment Byetta, made by Eli Lilly & Co. (LLY) and Amylin Pharmaceuticals Inc. (AMLN), amid reports the medicine may cause kidney problems.

From April 2005 through October 2008, the FDA has received 78 reports of patients taking Byetta who have had altered kidney function, including renal failure, according to an alert the agency sent to doctors on Monday. The alert was posted to the FDA's Web site.

The agency said it received 62 cases of acute renal failure and 16 cases of renal insufficiency in patients taking the medicine, which on Friday received FDA approval to be used as a stand-alone treatment for controlling sugar levels in patients with Type 2 diabetes. Previously, the drug had been approved only in patients who were also on other diabetes medications.

The FDA told doctors that some of the reports of kidney malfunction were in patients who had pre-existing kidney disease or with one or more risk factors for developing kidney problems.

From April 2005 through September 2008, more than 6.6 million prescriptions for Byetta were dispensed, the FDA said. "Therefore, the 78 reported cases of altered renal function represent a small percentage of the total number of patients who have used the drug," the agency said.

The FDA said the new label will include details of the reports of altered kidney function to allow doctors to "better weigh the known benefits of Byetta with the potential risks that exist for certain patients."

-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@dowjones.com

Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From May 2024 to Jun 2024