FDA Issues Glucose Monitoring Strip Alert
The Food and Drug Administration (FDA) is advising health care practitioners against using GDH-PQQ test strips for glucose monitoring in patients.
Patients who are also receiving therapeutic products containing certain non-glucose sugars may test with falsely elevated blood glucose levels when using GDH-PQQ test strips. Falsely elevated glucose results may mask significant hypoglycemia or promote excessive insulin administration, leading to serious injury or even death.
GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. When these non-glucose sugars are present in the patient’s blood, using a GDH-PQQ glucose test strip will produce an elevated glucose result, which may suggest the need for clinical action.
Unaffected methods that remain safe to use are glucose oxidase, glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), or glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD). Laboratory-based blood glucose assays also do not use GDH-PQQ methodology and are not subject to falsely elevated results from non-glucose sugars.
In addition to not using GDH-PQQ glucose test strips, the FDA has issued the following recommendations:
- If your facility currently uses GDH-PQQ glucose test strips, NEVER use them on patients:
- who are receiving interfering products**, or
- from whom or about whom you cannot obtain information regarding concomitant medication use, e.g., patients who are unresponsive or cannot adequately communicate.
**Interfering products containing non-glucose sugars include:
- Extraneal (icodextrin) peritoneal dialysis solution
- Some Immunoglobulins: Octagam 5%, Gamimune N 5%***, WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous(Human), and HepaGamB
- Orencia (abatacept)
- Adept adhesion reduction solution (4% icodextrin)
- BEXXAR radioimmunotherapy agent
- Any product containing, or metabolized into maltose, galactose or xylose.
Use ONLY laboratory-based glucose assays on these patients.
- Determine whether patients are receiving interfering products on admission and periodically during their stay at your facility.
- Educate staff and patients about the potential for falsely elevated glucose results in the presence of certain non-glucose sugars when using GDH-PQQ glucose test strips.
- Consider using drug interaction alerts in computer order entry systems, patient profiles and medical charts to alert staff to the potential for falsely elevated glucose results.
- Periodically verify glucose meter results with laboratory-based glucose assays if you are using GDH-PQQ test strips in patients who are not receiving interfering products.
*** Within the U.S., Gamimune N 5% has not been manufactured since December 2005, and no lots are in distribution in the U.S.
Report Adverse Events
From 1997-2009, the FDA has received 13 reports of death associated with GDH-PQQ glucose test strips. If you suspect a reportable adverse event associated with a glucose meter or glucose test strip, you should follow the reporting procedure established by your facility. If you suspect a falsely elevated blood glucose value associated with a non-glucose sugar interference, include information about the associated drug or biologic product in your adverse event report.
Read the full letter issued to health care practioners Aug. 13 by FDA Center for Devices and Radiological Health Director Daniel B. Schultz, M.D.