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Exenatide Label Updated to Highlight Kidney Risks
The type 2 diabetes drug exenatide (Byetta) will have a revision to its label warning of altered kidney function, according to the FDA.
The agency says it has received reports of over 60 cases of acute renal failure among patients on the drug. Some of the problems occurred in patients with existing renal disease.
The new label will advise against using exenatide in patients with severe renal impairment (creatinine clearance rates under 30 mL/min) or end-stage renal disease. In addition, it will urge caution when beginning or increasing doses of the drug in those with moderate impairment (creatinine clearance rates between 30 and 50 mL/min).
LINK(S):
FDA news release (Free)
FDA information for clinicians (Free)
Physician's First Watch coverage of exenatide and pancreatitis (Free)
Published in Physician's First Watch November 3, 2009
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