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FDA Issues New Biotin Safety Recommendations

NEW YORK – The US Food and Drug Administration on Tuesday updated its 2017 safety communication about the potential of biotin to interfere with laboratory tests.

The update is to remind consumers, healthcare providers, lab personnel, and lab test developers that biotin, often found in dietary supplements, can lead to incorrect lab test results, resulting in false high or low results. The agency is "particularly concerned about biotin interference causing a falsely low result for troponin," which is used to aid in diagnosing heart attacks, it said, adding that since it issued its safety communication two years ago, some lab test developers have successfully mitigated the biotin interference of their assays, but others "have not yet addressed" the issue.

According to the agency, many labs use biotin technology because they bond with specific proteins, which can be measured for certain health conditions.

For lab personnel, the FDA recommends that when taking patient samples, they ask patients whether they are taking biotin or supplements that contain biotin. Personnel should also educate patients about biotin interference with certain lab tests used in the labs. Additionally, they should "consider" that the daily recommended allowance for biotic is .03 mg for adults, an amount that typically does not cause significant interference. Some supplements marketed for nail, hair, and skin, however, may contain up to 20 mg of biotin.

Some specimens from patient taking high levels of biotin may contain more than 100 ng/mL biotin, the FDA said, adding current data is "insufficient to support recommendations for safe testing using affected tests in patients taking high levels of biotin, including about the length of time for biotin clearance from the blood."

The FDA recommends developers of lab tests contact the FDA if their tests use biotin technology. Further, such companies should investigate biotin interference in their assays that use biotin technology and determine the lowest concentration of biotin that may cause significant interference in their tests. The FDA recommends the test develops communicate with customers if they are unaware that their tests use biotin technology.

In June, the FDA issued a draft guidance that provides recommendations on testing for biotin interference with in vitro diagnostic devices.