GDH-PQQ Test Strips No Longer a Concern for SMBG Users

On August 13, the FDA made a public health notification that dangerous errors could result from the use of self-monitoring of blood glucose (SMBG) test strips incorporating the GDH-PQQ enzyme, one of the substances found on test strips that acts to measures blood glucose levels. The fatal errors were the result of simultaneous use of drugs that interfered artificially increased blood glucose readings three to 15 times actual levels. These interfering drugs were largely dialysis-related therapies, such as Extraneal, BEXXAR, and Orencia – overall, the FDA estimated the number of patients at risk of inaccurate meter readings to be very small.

Affected meters included Roche’s Accu-Chek, Abbott’s FreeStyle Lite, and Home Diagnostics’ TrueTest; Bayer and Johnson & Johnson’s LifeScan meters use an alternative substance and were never affected by GDH-PQQ concerns). However, at the time of the FDA’s public health notification, all companies using the GDH-PQQ enzyme had already taken action to develop new strips to prevent any errors from occurring – companies assured these will be compatible with current meters. Even if patients are currently using a Roche, Abbott, or Home Diagnostics meter, they can continue to use their meter with confidence as long as they are not using an interfering drug product or therapy (for a full list of interfering therapies, see here.