Safety Communication: Biotin May Interfere with Lab Test Results

The FDA has issued a Safety Communication about biotin, also known as vitamin B7. Taking high levels of it can significantly interfere with certain lab tests, rendering the results incorrect.

The agency has seen an increase in reported adverse effects from the incorrect lab results, including one death. The adverse events were related to interference with lab tests, due to biotin levels seen in blood or other samples from people who were taking high levels of biotin in dietary supplements. The death was due to “falsely low troponin test results when a troponin test known to have biotin interference was used.” Troponin is a marker for cardiac health.

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High dosages of biotin (up to 300 mg/day) are being investigated as a treatment for multiple sclerosis. OTC dietary supplements with biotin are marketed for hair, skin, and nails growth and may contain up to 650 times the recommended daily intake of the vitamin. It is also found in many multivitamin supplements and prenatal vitamin products. However, people taking products sold to help hair, skin, and nails may not be aware that one ingredient is biotin.

According to an FDA statement, many laboratory assays use biotin technology because it bonds with specific proteins which then can be measured to detect certain health conditions. These include hormone tests and cardiovascular diagnostic tests. Both patients and physicians may be unaware that biotin can interfere with test results and that patients may be taking higher levels of biotin than they realize.

The FDA is recommending that health-care professionals ask about any dietary supplements that patients may be taking. They should also be aware that the amounts of biotin in some dietary supplements can interfere with test results. The lab conducting the tests should be informed if the patient is taking biotin.

The full FDA statement is available here.