The U.S. Food and Drug Administration or FDA said that it has revised the Byetta label to include safety information on possible kidney problems.
From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function 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.
In response, Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co. (LLY) said that there is no evidence from preclinical and clinical studies that BYETTA has any direct toxic effect on the kidney.
The companies said, "The current label reflects their understanding of post-marketing reports of renal events and provides physicians with updated guidance about appropriate use in patients with renal conditions."
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