[acb-diabetics] FW: [diabetesworld] Byetta (exenatide) - Altered kidney function, including acute renal failure/renal insufficiency, in patients on Byetta

Tue Nov 3 15:55:44 GMT 2009

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From: diabetesworld at yahoogroups.com [mailto:diabetesworld at yahoogroups.com]
On Behalf Of John S Wilkinson
Sent: Tuesday, November 03, 2009 4:34 AM
To: Diabetesworld
Subject: [diabetesworld] Byetta (exenatide) - Altered kidney function,
including acute renal failure/renal insufficiency, in patients on Byetta

Byetta (exenatide) - Altered kidney function, including acute renal
failure/renal insufficiency, in patients on Byetta

Byetta (exenatide) - Renal Failure
Audience: Endocrine and nephrology healthcare professionals

FDA notified healthcare professionals of revisions to the prescribing
information for Byetta (exenatide) to include information on post-marketing
reports of altered kidney function, including acute renal failure and
insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to
diet and exercise to improve glycemic control in adults with type 2 diabetes
mellitus.

>From April 2005 through October 2008, FDA 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. Labeling changes include:

a.. Information regarding post-market reports of acute renal failure and
insufficiency, highlighting that Byetta should not be used in patients with
severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal
disease.
b.. Recommendations to healthcare professionals that caution should be
applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg
in patients with moderate renal impairment (creatinine clearance 30 to 50
ml/min).
c.. Recommendations that healthcare professionals monitor patients
carefully for the development of kidney dysfunction, and evaluate the
continued need for Byetta if kidney dysfunction is suspected while using the
product.
d.. Information about kidney dysfunction in the patient Medication Guide
to help patients understand the benefits and potential risks associated with
Byetta.
Read the complete MedWatch 2009 safety summary, including a link to the
Healthcare Professional information sheet, at:

http://www.fda.
<http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe
d> gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMed
icalProducts/ucm188703.htm

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