Drug & Device News

The U.S. Food and Drug Administration (FDA) is advising health care providers that their patients should not use certain glucose monitoring methods if they are also receiving therapeutic products containing non-glucose sugars, such as peritoneal dialysis solutions and certain immunoglobulins. The glucose test strips causing concern are those containing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ), including certain AccuCheck test strips, manufactured by Roche Diagnostics, and some Freestyle brand test strips, manufactured by Abbott Diabetes Care. These products can falsely elevate glucose results, which may prompt patients to use or to be administered too much insulin. These therapeutic products, which are labeled to indicate that they may interfere with this particular glucose monitoring technology, are mostly used in patients with serious medical conditions, including kidney failure and moderate to severe rheumatoid arthritis. The affected products are listed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm#attachment.

The agency's Aug. 14 Public Health Advisory tells health care facilities that they should not to use GDH-PQQ-containing test strips, and should opt instead for other means of measuring glucose, including glucose oxidase, glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), or glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD) methods. If they do use GDH-PQQ-containing test strips, health care providers should use them only on certain patients, and under particular circumstances, as outlined in the agency's release, which can be accessed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm.