Red-Hand-letters: warning of falsification of laboratory results by Biotin
The companies that market Biotin-containing medicines for special medical purposes, to inform, in consultation with the Federal Institute for drugs and medical devices (BfArM) on the possible interference of Biotin with clinical laboratory tests. You indicate that Biotin laboratory can distort the results if the test principle is based on an interaction between Streptavidin and Biotin. It could lead to false-positive or false-negative results occur.
Biotin, also called Vitamin B7 or Vitamin H, is, depending on the drug, for the treatment of Biotin deficiency, as well as to the corresponding supply of vitamins for the daily needs in the context of a parenteral nutrition is indicated. In addition, an early and life‐long Biotin therapy in congenital defects in Biotin metabolism (including Holocarboxylase Synthetase and biotinidase deficiency) is essential. A so-called high‐dose Biotin therapy of 300 milligrams per day is being investigated in clinical studies in adult patients for the treatment of progressive Multiple sclerosis. In the absence of appropriate dosage forms and Strengths could be used in individual patients, the Biotin-containing formulation, medicines for the application. Also on the German market with numerous Biotin-containing dietary supplements for the promotion of metabolism and the maintenance of nails, hair and skin are available.
Be take affected patients, the medicines and food supplements or dietary foods for special medical purposes, the ≥ that contain 150 micrograms of Biotin per unit Dose, or medicines for parenteral administration, administered to them, the ≥ that contain 60 micrograms of Biotin per unit Dose.
The patient should be questioned therefore, a laboratory study of a Biotin intake. If it is necessary. should consultation with the laboratory and near-patient diagnostics will be tested whether biotinylated reagents can be used.
In addition, the possibility of a Biotin-should-interference in the case of discrepancy between the laboratory and the clinical symptoms, or other investigations to be considered.
Special attention is required when high-dose Biotin therapy, renal failure, newborn, children and Pregnant women.
The pharmacist should inform the delivery of Biotin-containing products patients about the risk. If the risk of a Biotin-is interference, should alternative test methods be preferred. Click here for the Red-Hand-letter.