FDA: Biotin Interference With Troponin, Lab Tests Still a Concern

Megan Brooks

November 05, 2019

The US Food and Drug Administration (FDA) remains concerned about the potential of biotin, or vitamin B7, to interfere with the results of laboratory testing, including troponin testing for diagnosis of myocardial infarction (MI), the agency said today in an updated safety communication.

The FDA first issued a safety alert on this issue 2 years ago, noting that the supplement may cause falsely high or falsely low results, depending on the test, leading to inappropriate patient management or misdiagnosis, as reported by Medscape Medical News.

Since the FDA's 2017 safety communication, some lab test developers successfully mitigated the biotin interference of their assays, but others have not yet addressed it, the agency said today.

However, the FDA continues to receive adverse event reports that indicate that biotin interference may cause falsely low troponin results, the statement notes.

Prior to the 2017 safety communication, the FDA had received a report that one patient taking high levels of biotin died following low troponin results when a troponin test subject to biotin interference was used.

The agency created the Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference webpage to let providers known about troponin assays where the risk for biotin interference has yet to be addressed.

The FDA is continuing to monitor reports of adverse events associated with biotin interference with laboratory tests and will provide updates as needed. They encourage healthcare providers to report relevant adverse events to MedWatch.

The FDA continues to recommend health providers do the following:

  • Talk to patients about any biotin supplements they may be taking, including supplements marketed for hair, skin, and nail growth.

  • Be aware that many laboratory tests, "including but not limited to cardiovascular diagnostic tests and hormone tests," that use biotin technology are potentially affected and may provide incorrect results if there is biotin in the patient's specimen.

  • Communicate to the lab conducting the testing if the patient is taking biotin.

  • If a lab result doesn't match the clinical presentation of the patient, physicians should consider biotin interference as a possible source of error.

  • Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth, in levels that may interfere with lab tests.

  • Report to the lab test manufacturer and the FDA if physicians become aware of a patient experiencing an adverse event following potentially incorrect laboratory test results due to biotin interference.

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