Biotin can interfere with certain lab tests, cause incorrect results that may go undetected: FDA

Biotin interference causes falsely low result for troponin, clinically important biomarker to aid in diagnosis of heart attacks

The US Food and Drug Administration updated its safety communication to remind the public, healthcare 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.