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FDA Warns Biotin May Interfere With Lab Tests

NEW YORK (360Dx) – The US Food and Drug Administration has issued a warning that ingesting high levels of biotin, also known as vitamin B7, can lead to incorrect lab test results.

The agency said it issued the warning because it is seeing an increase in the number of reported adverse effects related to the vitamin's impact on lab results, including one death of a patient taking high levels of biotin whose troponin tests results were falsely low.

Biotin, a water-soluble vitamin often found in multi-vitamins, prenatal vitamins, and dietary supplements marketed for hair, skin and nail growth, can cause falsely high or falsely low results lab test results depending on the indication, according to the FDA.

Troponin, for example, is a clinically important biomarker in the diagnosis of heart attacks. The patient who died following a falsely low troponin test was given a test that is known to have biotin interference, according to the agency.

Many of the dietary supplements promoted for hair, skin and nail benefits contain biotin levels up to 650 times the recommended daily intake, according to the FDA. Physicians sometimes also recommend high levels of biotin for certain conditions such as multiple sclerosis. Even physicians who are aware of biotin interference with lab tests may be unaware how much biotin patients are ingesting, as patients taking dietary supplements might not report them to their physician, the agency warned.

The FDA recommended that consumers talk to their doctors about the dietary supplements they are taking and be aware of the vitamins that they include. The agency also recommended that consumers talk to their physicians if they are taking biotin and have concerns about the accuracy of their lab test results.

The agency is advising physicians to be aware that many lab tests, including cardiovascular diagnostic tests and hormone tests, may generate incorrect results if there is biotin in the patient's specimen. Physicians are also advised to tell the labs performing testing if patients are taking biotin. They are also warned to consider biotin levels if lab tests do not match patient presentation, and report back to the lab test manufacturer and the FDA if a patient experiences an adverse event following potentially incorrect lab test results that could be due to biotin interference.

Currently, there is insufficient data to support recommendations for safe testing of patients taking high levels of biotin, according to the FDA. Lab personnel are advised to be aware of the interference and discuss biotin levels with physicians, particularly when using assays with biotin technology.

Manufacturers of lab tests that use biotin technology are advised to determine the lowest concentration of biotin that may cause significant test interference, and contact the FDA about the interference. Labs are advised to investigate interference of up to 1200 ng/mL biotin in assays.

The FDA said it is working with stakeholders to better understand biotin interference with laboratory tests and to make appropriate recommendations. The agency is currently monitoring reports of adverse effects of the vitamin.