FDA Safety Communication Update: Biotin May Interfere with Lab Test Results

​On November 5, 2019, the FDA updated its 2017 safety communication to remind patients, healthcare professionals, and laboratory technicians that levels of biotin or B-7, a B-complex vitamin and a common component of dietary supplements, higher than the recommended daily allowance may interfere with lab test results.   
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Many dietary supplements promoted for hair, skin, and nails contain biotin levels up to 650 times the recommended daily intake of biotin. Physicians may also recommend high levels of biotin for patients with certain conditions such as multiple sclerosis. Biotin levels higher than the recommended daily allowance may cause interference with lab tests.
 
In its most recent update, the FDA reminds the public, healthcare providers, lab personnel, and lab test developers that biotin, often found in dietary supplements, can cause clinically significant incorrect lab test results. The FDA has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests. Incorrect test results may lead to inappropriate patient management or misdiagnosis. Biotin in patient samples can cause falsely high or falsely low results, which may lead to inappropriate patient management or misdiagnosis. For example, a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, may lead to a missed diagnosis and potentially serious clinical implications.
 
Consumers are advised to tell their doctor if they are taking biotin. Healthcare providers should talk to their patients about any biotin supplements they may be taking. Know that biotin is found in multivitamins – including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth – at levels that may interfere with lab tests. Lab personnel using assays with biotin technology must educate themselves and others about the potential for biotin interference.
 
The recommended daily allowance of biotin is 0.03 mg and biotin is present in small amounts in many foods including whole grains, eggs, walnuts, avocados, egg yolk, liver, and yeast.

Forms for healthcare professionals and patients to report safety information: 
https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/medical-product-safety-information
FDA Safety Communication:
https://www.fda.gov/medical-devices/safety-communications/update-fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication