USA – FDA updates safety recommendations on biotin interference in lab tests

The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication to remind the public, health care providers, lab personnel, and lab test developers that biotin, often found in dietary supplements, can significantly interfere with certain lab tests and cause incorrect results that may go undetected. The FDA wants to make the public and health care providers aware about biotin interference with lab tests so that patients, physicians, and laboratories can work together to help prevent adverse events.

As noted in the original safety communication, while biotin in patient samples can cause falsely high or falsely low results, depending on the type of test, 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 clinical implications. The FDA continues to receive adverse events reports indicating biotin interference caused falsely low troponin results.

Since the FDA‘s safety communication on this topic in 2017, some lab test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it. The FDA remains concerned about troponin laboratory tests that have not addressed the risk of biotin interference. The FDA has posted a webpage on Biotin Interference with Troponin Lab Tests – Assays Subject to Biotin Interference to notify the public about troponin assays where the risk of biotin interference has not yet been addressed…