Erratum: The previously posted Important Safety Information (November 4, 2005) on this subject contained incorrect information. That is, the notice included a list of glucose measurement systems that provide falsely elevated glucose readings in patients receiving parenteral drug products containing maltose or galactose, or oral d-xylose. This list included certain systems using glucose dehydrogenase enzyme with NAD as co-factor (GDH-NAD). However, glucose measuring systems using GDH-NAD do not exhibit interference as a result of cross reacting sugars as described in this notice. Falsely elevated glucose results will not be observed when using GDH-NAD systems for patients receiving products containing the listed cross reacting sugars. We regret any confusion the previous communication may have caused.
This notice is intended to alert physicians, nurses, medical technologists, pharmacists and other healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose, and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. The GDH-PQQ method of glucose determination is non-specific for glucose and, in the presence of maltose, xylose, or galactose, may yield falsely elevated glucose readings.
Although this is a known drug-device interaction (1-5), there have been reports of the inappropriate administration of insulin and consequent life-threatening/ fatal hypoglycemia in response to erroneous test results obtained from patients receiving parenteral products containing maltose. Cases of true hypoglycemia can go untreated if the hypoglycemic state is masked by false elevation of glucose readings. Since hypoglycemia may be life threatening, it is important that health care providers prescribing and/or administering products containing the above sugars be aware of possible interference leading to incorrect results. A preliminary listing of U.S. products that may cause interference is presented in Table 1.
The following precautions should be taken when patients are receiving products containing the sugars maltose (or sugars which are metabolized to maltose, such as peritoneal dialysis solutions containing icodextrin [e.g., EXTRANEAL]), xylose or galactose:
- Review the labeling for both the glucose meter and the test strips to be used to monitor glucose levels to determine what type of method is used for glucose determination.
- Use only test methods not affected by the presence of maltose, galactose, or d-xylose, such as glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase- or glucose hexokinase-based test methods.
- If in doubt, contact the manufacturer of the glucose monitoring system to determine the specific type of testing that is used in their system.
We advise healthcare providers who prescribe a GDH-PQQ method of glucose determination to individuals for whom blood sugar measurements are routinely performed on an outpatient basis, to notify patients who may be receiving a parenteral product containing maltose or galactose, or oral xylose, to use only those glucose testing methodologies for blood sugar monitoring that are not subject to interference.
For additional information on the subject, readers should refer to the FDA Reminders For Falsely Elevated Glucose Readings.
Table 1: Preliminary lista of U.S. products that may interfere with GDH-PQQ based glucose monitoring systems.
|Octapharma||Octagam 5%||Immune Globulin Intravenous (Human)||Maltose||10%|
|Talecris||Gamimune N 5%||Immune Globulin Intravenous (Human) 5% Solvent/Detergent Treated||Maltose||9-11%|
|Cangeneb||WinRho SDF Liquid||Rho(D) Immune Globulin Intravenous (Human)||Maltose||10%|
|Cangene||Vaccinia Immune Globulin (Human)||Vaccinia Immune Globulin (Human)||Maltose||10%|
|Cangene||HepaGamB||Hepatitis B Immune Globulin Intravenous (Human)||Maltose||10%|
|NERL Diagnostics, others||D-Xylose USP||d-Xylose||d-Xylose||Usual dose 25g|
|Baxter||Extraneal||(icodextrin) Peritoneal Dialysis Solution||icodextrin||7.5 gm/100 ml|
aThis list will be updated as information on additional potentially interfering products is received.
bPreliminary calculations suggest that, when WinRho SDF Liquid is administered at the recommended doses, the peak blood concentration of maltose is unlikely to interfere with glucose testing by GDH-PQQ-based methods.
- ISMP Medication Safety Alert. Be aware of false glucose results with point-of-care testing. 2005;10 (18):13.
- ISMP Errata re: Medication Safety Alert. Be aware of false glucose results with point-of-care testing. 2005;10 (19):3.
- Medical Device Alert. Medicines and Healthcare Products Regulatory Agency. April 16, 2003.
- Octagam® package insert.
- GA News. Australian Government Dept. of health and Ageing Therapeutic Goods Administration. Issue 46 (April 2005)