The FDA is alerting the public, healthcare providers and lab personnel that biotin can significantly interfere with certain lab tests, leading to incorrect test results that may go undetected.
Biotin, also known as vitamin B7, is a water-soluble vitamin often found in multivitamins, prenatal vitamins, and dietary supplements marketed for hair, skin and nail growth.
Many lab tests use biotin technology due to its ability to bond with specific proteins, which can be measured to detect certain health conditions. For example, biotin is used in hormone tests and tests for markers of cardiac health like troponin.
Biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results.
The US agency said it has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.
Biotin in patient samples can cause falsely high or falsely low results, depending on the test, with the risk of leading to inappropriate patient management or misdiagnosis.
The FDA has received a report that one patient taking high levels of biotin died following falsely low troponin test results when a troponin test known to have biotin interference was used.
People are taking high levels of biotin, the FDA said, pointing out that many dietary supplements promoted for hair, skin and nail benefits contain biotin levels up to 650 times the recommended daily intake of the ingredient. Physicians may also be recommending high levels of biotin for patients with certain conditions, such as multiple sclerosis (MS).
Even physicians who are aware of this interference are likely unaware as to whether, and how much biotin, patients are taking. Since patients are unaware of biotin interference, patients may not report taking biotin supplements to their physicians, and may even be unaware they are taking biotin (e.g., when taking products generally labelled for their benefits to hair and nails).
The FDA is working with stakeholders to better understand biotin interference with laboratory tests, and to develop additional future recommendations for safe testing in patients who have taken high levels of biotin when using laboratory tests that use biotin technology.