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FDA issues warning over certain diabetes test strips

8/14/2009

ROCKVILLE, Md. The Food and Drug Administration issued an advisory Friday warning healthcare practitioners against using a type of glucose test strip in diabetes patients because it may produce falsely high blood-sugar results when the patients are using therapies containing nonglucose sugars.

The FDA said non-glucose sugar products in some products such as peritoneal dialysis solutions and some immunoglobulins, mostly used in patients with kidney failure and rheumatoid arthritis, can falsely elevate glucose results if used along side test strips that use glucose dehydrogenase pyrroloquinoline quinone, which could prompt administration of too much insulin.

Most GDH-PQQ devices are used in healthcare facilities, and Bayer Diabetes Care released a statement earlier saying that its diabetes testing products did not use GDH-PQQ.

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