Alerts
Galactose, Maltose, and Xylose Products May Falsely Elevate Glucose Results – Update
August 14, 2009
Due to increasing reports of fatal hypoglycemic events, FDA recommends that all healthcare facilities avoid the use of glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) glucose test strips. Parenteral agents containing galactose or maltose and oral agents containing d-Xylose can interfere with GDH-PQQ blood glucose testing, resulting in falsely elevated values. Multiple fatal hypoglycemic events associated with this interaction have been reported to the FDA since 1997, many within the last year.
FDA recommends using laboratory-based glucose testing for patients receiving d-xylose, icodextrin peritoneal dialysis solution, Octagam 5%, , WinRho SDF liquid, HepaGamB, Orencia (abatacept), Adept adhesion reduction solution (4% icodextrin), BEXXAR radioimmunotherapy agent, or any other product containing or metabolized to a non-glucose sugar. Other recommendations include determining possible interacting products upon patient admission, computerized drug-interaction alerts, and periodic laboratory-based glucose testing in all patients.
Laboratory-based testing and other glucose testing systems including glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD), and glucose oxidase methods are not affected by non-glucose sugars and do not provide falsely elevated values. See the link below for a list of GDH-PQQ glucose test strips.
Additional information is available at the following links:
- MedWatch Alert:
- August 14, 2009
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm177295.htm - April 22, 2008
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm153046.htm - FDA Safety Information:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm - Final FDA Report:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm155099.htm - Public Health Notification:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm - List of GDH-PQQ Glucose Test Strips (as of August 2009):
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications /ucm176992.htm#attachment - Advice for Patients:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm177189.htm
Updated
August 14, 2009; August 21, 2006; November 14, 2005; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
