November 5, 2019
“We want to remind the public about risks that can arise when vitamin B7, or biotin, found in many multi-vitamins, interferes with certain diagnostic tests, including some tests for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks. This interference may cause falsely low results for the presence of troponin, which could lead to missed diagnoses or serious health consequences. As part of our continued efforts to communicate about this risk, we’re releasing the names of specific troponin tests for which this type of interference has not been addressed in an effort to help patients, their health care professionals and laboratory personnel be aware of which tests may be impacted,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “In 2017, the FDA identified a significant safety issue with biotin interference with certain in vitro diagnostic tests and issued a safety communication containing recommendations to the public to help mitigate potential biotin interference and warning that biotin interference with certain lab tests, including troponin tests, may lead to faulty results. 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.”
Today, the U.S. Food and Drug Administration updated its safety communication to remind the public, health care providers, lab personnel and lab test developers that biotin, also known as vitamin B7, often found in dietary supplements, can significantly interfere with certain lab tests and cause incorrect results that may go undetected. The FDA is particularly concerned about biotin interference causing a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, which may lead to a missed diagnosis and potentially serious health implications.
Biotin is a water-soluble vitamin often found in multi-vitamins, prenatal vitamins and dietary supplements marketed for hair, skin and nail growth. Many dietary supplements contain biotin levels up to 650 times the recommended daily intake of biotin. The presence of high levels of biotin in patients’ blood can cause clinically significant incorrect results in certain lab tests, leading to falsely high or falsely low results, depending on the type of test.
Since first communicating on this issue in 2017, the agency has continued to receive adverse events reports related to biotin interference, including with troponin tests. The FDA has engaged with manufacturers to address the risk of biotin interference in their assays, and many test makers have taken steps to mitigate the issue. However, not all manufacturers have done so, which is why, in order to foster transparency and inform the public, the agency is releasing a list of troponin tests in the FDA’s listing database that have not yet mitigated the biotin interference risk. The FDA will continue engaging with manufacturers as they work to address this interference and will update the list of troponin tests subject to biotin interference as appropriate. Additionally, the agency is reminding patients and health care providers to discuss all supplement use. The FDA will continue to update the public if significant new information becomes available.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.