The U.S. Food and Drug Administration (FDA) has notified healthcare professionals regarding the potential for falsely elevated glucose readings in patients tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ)–glucose monitoring systems after receiving other sugars.
Because the GDH-PQQ method is not glucose-specific, readings may be falsely increased in patients receiving oral d-xylose or parenteral drug products containing maltose or galactose, according to an alert sent today from MedWatch, the FDA’s safety information and adverse event reporting system.
Although this is a known drug-device interaction, the FDA has received reports of fatal and life-threatening hypoglycemia due to inappropriate insulin administration in patients with erroneously high glucose readings obtained while using maltose-containing parenteral products.
In addition, such readings may mask cases of potentially life-threatening true hypoglycemia.
Patients receiving products containing maltose (or sugars that are metabolized to maltose such as icodextrin), galactose, or xylose should be tested using glucose dehydrogenase nicotine–adenine dinucleotide (GDH-NAD), glucose oxidase– or glucose hexokinase–based tests.
A preliminary list of products that may interfere with GDH-PQQ–based glucose meters is available at https://www.fda.gov/cber/safety/maltose110405.htm. Healthcare professionals who prescribe a GDH-PQQ–based method for routine outpatient glucose monitoring are advised to notify affected patients regarding the need for glucose-specific testing.
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