Pharmacy Services Alerts
Biotin (Vitamin B7) May Interfere with Laboratory Test Results Leading to Inaccurate Interpretation - UPDATED
Nov 6, 2019 1:45 PM
FDA issued a MedWatch alert in 2017 regarding the interference of biotin (vitamin B7) with laboratory test results. FDA is reminding consumers and healthcare professionals about this issue. Biotin is used in certain laboratory tests to bind proteins that can then be measured for diagnostic purposes. High concentrations of biotin in the blood can interfere with these laboratory tests leading to misinterpretation of test results and incorrect patient diagnoses. Biotin may falsely elevate or lower test results. Specific tests that may be affected by biotin concentrations include cardiac diagnostic tests (eg, troponin tests) and hormone tests. There has been an increase in adverse events reported to FDA related to biotin interference. One death related to a falsely low troponin caused by biotin interference has been reported. FDA continues to receive reports of adverse events due to this lab interference.
Many dietary supplements including multivitamins and products marketed for hair, skin, and nail health may contain biotin. The recommended daily allowance of biotin is 0.03 mg. Dietary supplements may contain up to 650 times the recommended daily intake of biotin. Some patients may also be prescribed high doses of biotin in certain medical conditions (eg, multiple sclerosis). Patients may be unaware they are taking biotin, and may not report taking biotin-containing supplements. Data are not available to know how long to stop taking the medication to prevent interference with lab testing.
Health care providers should communicate with the laboratory if tests using biotin technology are ordered in patients taking biotin. Consider biotin interference if a test result does not match a patient’s clinical presentation. Report any incorrect test results due to biotin interference to the test manufacturer and FDA.
Laboratory personnel educate providers regarding which laboratory tests use biotin technology. There are currently insufficient data regarding laboratory testing recommendations in patients with high serum biotin concentrations. Contact the manufacturer of specific laboratory tests with questions regarding biotin interference.
Laboratory test manufacturers should contact FDA and customers if tests they produce use biotin technology. Manufacturers should also determine the lowest serum biotin concentration at which clinically significant interference may occur.
Consumers should talk with their health care providers if currently taking or considering taking biotin‑containing supplements. Contact a health care provider if concerned about biotin interference in laboratory test results.
FDA is working to better understand biotin interference, and will develop recommendations for laboratory testing in patients with high serum biotin concentrations. FDA will continue to monitor reports of biotin interference, and will update the public when more data are available.
FDA has published a list of devices that are at risk for biotin interference at www.fda.gov/medical-devices/vitro-diagnostics/biotin-interference-troponin-lab-tests-assays-subject-biotin-interference.
More information is available at the following links:
FDA Safety Communication – November 5, 2019
FDA Safety Alert – November 28, 2017