FDA is warning people that Biotin, also known as vitamin B7, which is most often touted for its hair, skin, and nail benefits, can interfere with certain laboratory tests.Pixabay
FDA is warning the public, healthcare providers, laboratory personnel, and lab test developers that an ingredient commonly found in certain dietary supplements can cause false test results.
Many lab tests use biotin technology due to its ability to bond with specific proteins that can be measured to detect certain health conditions. for example, biotin is used in hormone tests and tests for markers of cardiac health like troponin. The agency said some supplements, particularly those marketed for hair, skin, and nail benefits, may have high doses of biotin, which may not be clear from the label. Biotin, also known as vitamin B7, is also used in some prenatal and multivitamins.
Biotin in patient samples can cause falsely high or falsely low results, depending on the test, FDA said. The agency said it has noticed an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests. The patient death was linked to falsely low troponin test results when a troponin test known to have biotin interference was used.
A lot of dietary supplements promoted for hair, skin, and nail benefits contain biotin levels up to 650 times the recommended daily intake, FDA said. Doctors may also be recommending high levels of biotin for patients with certain conditions such as multiple sclerosis.
FDA said lab test manufacturers with assays that use biotin technology should contact the agency to discuss biotin interference. Manufacturers should also investigate interference from biotin (up to at least 1200 ng/mL biotin) in assays that use biotin technology, and determine the lowest concentration of biotin that may cause clinically significant interference, the agency said.
In addition to monitoring reports of adverse events linked to biotin interference, FDA said it is working to better understand biotin interference with lab tests, and to develop additional safe-testing recommendations in patients who have taken high levels of biotin when using laboratory tests that use biotin technology.