FDA: Vitamin B7 May Interfere With Lab Tests for Hormone Levels
Concentrations of biotin up to 1200 ng/mL may be present in specimens collected from patients taking up to 300 mg per day.
The Food and Drug Administration (FDA) has issued a safety communication alerting healthcare professionals that biotin can significantly interfere with certain lab tests and cause incorrect results which may go undetected.
Biotin (vitamin B7), a water-soluble vitamin, is often found in multivitamins, prenatal vitamins, and dietary supplements. As many lab tests use biotin technology due its ability to bond with specific proteins, ingesting high levels of biotin can cause clinically significant incorrect lab results.
Reports of biotin interference have been increasing, with one death already reported to the FDA. In this case, a patient who was taking high levels of biotin died after receiving a falsely low troponin test result when a troponin test known to have biotin interference was used.
The FDA recommends clinicians do the following to prevent these adverse events:
- Talk to patients about any biotin supplements they may be taking
- Be aware that certain lab tests use biotin technology (ie, cardiovascular diagnostic tests, hormone tests) and that results may be potentially affected if there is biotin in the patient's specimen
- Let the lab conducting the test know that the patient is taking biotin
- Consider biotin inference as a possible error if the test results do not match with clinical presentation
- Report adverse events following potentially incorrect lab test results due to biotin interference to the lab test manufacturer and the FDA
The FDA is monitoring for reports of biotin interference with lab tests and will update the public as new information becomes available. Adverse events related to this issue can be reported to MedWatch.
Biotin (vitamin B7): safety communication - may interfere with lab tests [news release]. Silver Springs, MD: US Food and Drug Administration. Published November 28, 2017. Accessed November 29, 2017.