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FDA Warns About Biotin Interference With Lab Tests

by | Jan 8, 2018 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Testing Trends-dtet

In late November the U.S. Food and Drug Administration issued a safety communication warning that the supplement biotin (Vitamin B7) may interfere with laboratory testing results. The warning comes after Roche Diagnostics (Indianapolis, Indiana) published a study online Sept. 14 in the International Journal of Pharmacokinetics demonstrating that an eighthour wait time or washout period is necessary for accurate test results when using streptavidin–biotin immunoassays following high doses of biotin (more than 5 mg/day). The FDA says it has received a report that one patient taking high levels of biotin died following falsely low troponin results on a test for heart attacks known to have biotin interference. There have been previous case reports of biotin interference leading to incorrect diagnoses in both adults and children, particularly for cardiovascular diagnostic tests and hormone tests. However, there is increasing use of over-the-counter (OTC) biotin supplements that purportedly strengthen hair, skin, and nails. These products range in biotin doses from 50 μg in multivitamin to as high as 10 mg in some biotin-only products. The FDA notes these high-dose OTC products may contain biotin levels up to 650 times the recommended daily intake of biotin (30 μg/day). Additionally, physicians recommend extremely high doses […]

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