November 05, 2019
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FDA: Risk for biotin interference with lab tests, troponin remains a concern

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The FDA has updated its safety communication to remind the public, health care providers, lab personnel and lab test developers that biotin, or vitamin B7, can significantly interfere with certain diagnostic tests and cause incorrect results that may go undetected. The FDA remains concerned, in particular, with the potential for false results for troponin, which could result in missed diagnoses for MI.

“[T]his interference may cause falsely low results for the presence of troponin, which could lead to missed diagnoses or serious health consequences,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, stated in the safety communication issued on Nov. 5.

The FDA continues to receive adverse event reports indicating biotin interference caused falsely low troponin results, according to the statement.

The FDA first issued a safety communication in 2017 on biotin interference with certain in vitro diagnostic tests and has since issued recommendations to mitigate the potential for interference.

“While there are troponin tests on the market that are not affected by this interference, and several for which manufacturers have already addressed this issue, others remain on the market with the potential for this harmful interference. As part of our commitment to protecting public health and protecting patients, we’re communicating today to be transparent about the affected tests and provide as much detail as possible to the public,” Stenzel stated in the release.

The FDA today released a list of troponin tests in the FDA’s listing database that have not yet mitigated the biotin interference risk, according to the communication.

The FDA has updated its safety communication to remind the public, health care providers, lab personnel and lab test developers that biotin, or vitamin B7, can significantly interfere with certain diagnostic tests and cause incorrect results that may go undetected.
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Biotin is a water-soluble vitamin often found in multivitamins, prenatal vitamins and dietary supplements marketed for hair, skin and nail growth. Many dietary supplements contain up to 650 times more biotin than recommended daily values. Many lab tests use biotin technology as it bonds with specific proteins that can be measured to detect certain health conditions, according to the agency.

The FDA recommends that health care providers discuss with patients any biotin supplements or multivitamin supplements they are taking that may contain biotin and to communicate that information to the lab conducting the testing. - by Scott Buzby