FDA Issues Biotin Warning

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Capitol Hill

Washington, DC — The U.S. Food and Drug Administration (FDA) has issued a warning that biotin (vitamin B7) may interfere with laboratory tests and cause incorrect lab test results.

“Some supplements, particularly those labeled for hair, skin and nail benefits, may have high doses of biotin, which may not be clear from the label,” said the FDA in a public statement.

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 FDA said, adding it has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.

“If the FDA wants to protect the public from the dangers of false lab results from biotin interference they have the authority to ban the clinical use of biotin based methods,” one  lab director told WholeFoods in an email. “TOSOH and Abbott immunoassays do not use biotin-based methods.”

“To successfully manage risks associated with biotin interference, clinical laboratory professionals can benefit from a better understanding of vitamin supplementation trends, therapeutic uses of biotin, the prevalence of biotin-based immunoassays, immunoassay designs, biotin interference mechanisms, and strategies to mitigate this inference risk (such as the use of biotin-free assays),” wrote Lori Lai, in an article published in Medical Laboratory Observer on June 22.

Biotin in patient samples can cause falsely high or falsely low results, depending on the test, according to the FDA. Incorrect test results 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. 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.

Many lab tests use biotin technology due to its ability to bond with specific proteins which can be measured to detect certain health conditions. The FDA is aware of people taking high levels of biotin that would interfere with lab tests and dietary supplements with levels up to 650 times the recommended daily intake of biotin. There is no official RDA or RNI for biotin. General guidelines are 30 to 100 mcg daily for adolescents and adults.

“To successfully manage risks associated with biotin interference, clinical laboratory professionals can benefit from a better understanding of vitamin supplementation trends, therapeutic uses of biotin, the prevalence of biotin-based immunoassays, immunoassay designs, biotin interference mechanisms, and strategies to mitigate this inference risk (such as the use of biotin-free assays),”

Biotin, also known as vitamin B7, is a water-soluble vitamin often found in multi-vitamins, prenatal vitamins, and dietary supplements marketed for hair, skin, and nail growth. It is an essential nutrient that is naturally present in some foods.

Physicians may also be recommending high levels of biotin for patients with certain conditions such as multiple sclerosis (MS), the FDA said.

Posted on WholeFoods Magazine Online, 11/28/17

 

 

 

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