This blog tracks updates to the Blood Sugar 101 Web site.

Sunday, November 29, 2009

FDA Adds Warning: Don't Take Byetta If Kidneys Seriously Impaired

Page changed: Byetta.

Added the following:
In late 2009 the FDA analyzed postmarketing data for Byetta and found 78 cases of kidney failure reported between April 28, 2005 and October 29, 2008, a period in which more than 6.6 million prescriptions for Byetta had been dispensed.

Given the prevalence of kidney failure among people with established diabetes this finding may or may not be related to the drug. The FDA now states that Byetta should not be prescribed to people with "severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease." Caution should be used when prescribing it to people with "moderate renal impairment (creatinine clearance 30 to 50 ml/min)."

Because doctors are ignorant of or ignore FDA drug warnings check your creatinine clearance test results before you start Byetta. If your doctor has not given you this test once a year, find a new doctor. All people with diabetes should have their kidney function tested periodically.

Warning signals of kidney problems are: Increased serum creatinine, Changes in urination (color, frequency, amount), Unexplained swelling in the extremities, Increases in blood pressure, Lethargy, Dull ache in the mid to lower back. NOTE: Changes in appetite and digestion are also listed as symptoms of kidney dysfunction but are also normal responses to Byetta.

FDA Safety Information for Byetta

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