August 13, 2009

Dear Members:

The U.S. Food and Drug Administration (FDA) has just released a new Public Health Notification (PHN) on glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) glucose monitoring technology. This notification alerts healthcare practitioners to the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. The PHN recommends healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.

The Endocrine Society was consulted in the drafting of this Public Health Notification, and the FDA accepted a number of the Society's suggested changes.

Details of the Public Health Notification can be found at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm.   

Accompanying patient information can be found at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm177189.htm.