FDA Approves New Byetta Label Amid Renal-Failure Reports
November 02 2009 - 3:20PM
Dow Jones News
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. (AMLY), 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
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