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Patient Alerts

The Centers for Medicare & Medicaid Services and ESRD Networks were alerted by the Food and Drug Administration (FDA) to a concern with peritoneal dialysis patients' glucoses while on Icodextrin EXTRANEAL dialysis solution and the effects of falsely elevated glucoses because of interaction of maltose using some glucometers.

The FDA has added a "Special Warning" to the EXTRANEAL consumer information. The following warning has been added.

SPECIAL WARNINGS WITH EXTRANEAL:
"If you monitor your blood glucose, you must use a glucose specific monitor and test strips. If your monitor or test strips use a glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ) method, using EXTRANEAL may cause a falsely high glucose reading.

A false high blood glucose reading could cause you to give more insulin than you need. Getting more insulin than you need can lower your blood sugar unnecessarily and can cause a serious reaction including loss of consciousness.

You or your health care provider should contact the manufacturer(s) of the monitor and test strips you use to make sure that EXTRANEAL, icodextrin or maltose will not interfere with test results."

Additional information about EXTRANEAL and the warning can be found at the FDA website FDA.gov (type in Extraneal in the search box) or use the direct link below.
http://www.fda.gov/cder/consumerinfo/druginfo/extraneal.htm

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