The FDA has issued a new warning about the potential interference of biotin, or vitamin B7, with troponin testing, a crucial diagnostic tool for heart conditions. Biotin is a water-soluble vitamin found in many over-the-counter supplements, including multivitamins, prenatal vitamins, and products marketed for improving hair, skin, and nails.
Vitamin B7 plays an essential role in several laboratory assays, particularly those measuring troponin and thyroid hormone levels. When patients consume high doses of biotin, especially more than 30 mg daily, it can lead to inaccurate test results. Specifically, biotin can cause falsely low troponin levels in the blood. Troponin is a key marker used to detect heart disease and, more importantly, to diagnose acute events such as heart attacks (myocardial infarctions). Therefore, biotin interference can result in a dangerous underestimation of heart damage.
Cases of biotin use in doses as high as 300 mg daily have been observed, particularly in patients with multiple sclerosis. Such high intake can result in biotin blood concentrations as high as 1,200 ng/mL. Although biotin has a relatively short half-life of about two hours, its impact on laboratory tests can persist. Suspending biotin supplementation for two to three days before undergoing tests that use biotin-analyte technology may help mitigate this interference.
It is crucial for patients, healthcare providers, and laboratory personnel to be aware of the potential for biotin to interfere with blood tests, particularly those for troponin and thyroid hormones. In critical clinical situations, such as a suspected heart attack, undetected biotin interference could lead to a normal troponin reading despite the presence of cardiac damage. This could delay or prevent the diagnosis of a life-threatening event, ultimately affecting the timely initiation of life-saving treatments.
Biotin FDA Warning – November 2019
The FDA is updating the 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.
Recommendations for Consumers
- Talk to your doctor if you are currently taking biotin (also called vitamin B7) or are considering adding biotin, or a supplement containing biotin, to your diet.
- Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and supplements for hair, skin, and nail growth in levels that may interfere with laboratory tests. However, the amount of biotin can vary significantly among different products.
- However, supplements containing high biotin levels including those marketed for hair, skin, and nail benefits, may contain up to 20 mg of biotin, and physicians may recommend up to 300 mg per day for conditions such as multiple sclerosis.
- Biotin levels higher than the recommended daily allowance may cause significant interference with affected lab tests.
- Consider that the daily recommended allowance for biotin is 0.03 mg and that amount does not typically cause interference in lab tests