FDA Issues Warning on GDH-PQQ Test Strips

Glucose DeHydrogenase PyrroloQuinoline Quinone is a type of glucose monitoring technology  The FDA issued a health notice alerting anyone using GDH-PQQ technology and receiving drug therapies or products containing certain sugars other than glucose such as: maltose, xylose and galactose can lead to serious injury or death.

Drug products or therapies with non-glucose sugars

  • 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 that contains, or the body breaks down into, the sugars maltose, galactose or xylose

This is the reason for concern: These types of sugars can create a false glucose reading on your meter which will prompt more insulin coverage for a higher blood sugar leading to severe hypoglycemia. Hence the serious injury or death concern.

IMO this has to be very rare especially if you check your blood sugar often. Like me for instance 10-12x per day. Although not everyone is that anal retentive.

Who should be concerned with this? People on peritoneal dialysis and people who recently had surgery.

**Glucose test strips other than the GDH-PQQ type are not affected by this problem, and can be used by patients taking drug products or therapies that contain non-glucose sugars.

If you are concerned if your strips use this technology there is a list of GDH-PQQ Glucose Test Strips Here
Roche Diagnostics is among the listed with their ACCU-CHEK® test strips.

Andreas  Stuhr, MD, medical director of Roche Diabetes Care North America put out a patient letter today stating this:

It is important to know that this is not a recall of the ACCU-CHEK® blood glucose monitors

The FDA notes that “GDH-PQQ meters and strips are okay to use if you are not using an interfering drug product or therapy” as listed above.  For those who are using drugs that contain non-glucose sugars, the FDA recommends the following:

  • Do not use GDH-PQQ glucose meters or test strips

• Use another type of glucose monitoring technology and continue to monitor your blood glucose as instructed by your healthcare provider
• Contact your healthcare provider if your results do not reflect the way you feel

Patient safety is important to Roche.  ACCU-CHEK® products have been proven to provide accurate and reliable results for patients with diabetes, when used as directed in package inserts.

Should you have any additional questions or concerns regarding ACCU-CHEK® products, please call ACCU-CHEK® Customer Care, available twenty four hours, seven days a week at 1-800-858-8072.
Bayer Healthcare also contacted me as well with this statement:

Bayer’s CONTOUR and Bayer’s BREEZE2 Blood Glucose Monitoring Systems Do Not Use Problematic GDH-PQQ Technology

Bayer Diabetes Care is committed to patient safety and has a portfolio of blood glucose meters that all meet the current FDA requirements.  The company adheres to and supports the highest standard of quality in its meters and strives to do everything possible by a manufacturer to ensure the accuracy of readings. Bayer Diabetes Care meters are designed to minimize the impact from as many external variants as possible, helping to ensure accuracy of readings.  Bayer’s BREEZE®2 and CONTOUR® systems both feature No CodingTM technology, and no interference with common substances including the non-glucose sugars maltose and galactose.

For more information on Bayer Diabetes Care blood glucose monitoring systems, visit www.bayerdiabetes.com.