Biotin, also known as vitamin B7, is a water-soluble vitamin often found in multi-vitamins, prenatal vitamins, and dietary supplements marketed for hair, skin, and nail growth.
The agency stated that biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results. FDA noted an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.
Biotin in patient samples has been linked to falsely high or falsely low results, FDA said, depending on the test. Incorrect test results may lead to inappropriate patient management or misdiagnosis. For example, a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, may lead to a missed diagnosis and potentially serious clinical implications. The FDA went on to say it has received a report that one patient taking high levels of biotin died following falsely low troponin test results when a troponin test known to have biotin interference was used.
FDA recognized that many dietary supplements promoted for hair, skin, and nail benefits contain biotin levels up to 650 times the recommended daily intake of biotin, and that physicians also recommend high levels of biotin for patients with certain conditions such as multiple sclerosis (MS). Biotin levels higher than the recommended daily allowance may cause interference with lab tests.
The alert cautions that patients and physicians may be unaware of biotin interference in laboratory assays. Even physicians who are aware of this interference are likely unaware as to whether, and how much biotin, patients are taking, FDA said. Since patients are unaware of biotin interference, patients may not report taking biotin supplements to their physicians, and may even be unware they are taking biotin (e.g., when taking products generally labeled for their benefits to hair and nails).
The FDA is currently working with stakeholders to better understand biotin interference with laboratory tests, and is developing additional future recommendations for safe testing in patients who have taken high levels of biotin when using laboratory tests that use biotin technology.
Commenting on FDA’s biotin alert, Duffy MacKay, N.D., senior vice president, scientific & regulatory affairs, the Council for Responsible Nutrition (CRN), stated:
"Biotin is a safe nutrient and FDA has not identified any health concerns with biotin supplementation. The concerns raised by FDA are specifically directed to potential interference with certain lab tests. The simplest and most effective way to address these concerns is for healthcare practitioners to alert patients to temporarily stop taking their biotin supplements before getting blood work. The take-home reminder for consumers is that it is always important for them to talk to their healthcare practitioners about all of the dietary supplements, over-the-counter products and prescription drugs they are taking in order to prevent interactions and lab errors.
We appreciate FDA taking seriously its responsibility of monitoring the Serious Adverse Event reporting (SAERs) system. CRN lobbied for the law which created mandatory reporting of SAERs because we understand it provides a way for the regulatory agency to identify signals and patterns that may indicate a potential safety issue. When this monitoring of adverse event data suggests a product may interfere with a medical test, as happened in this case, then it is important that this data be shared with the healthcare community and publicly. However, it is also important that the results not be over- or misinterpreted, resulting in concerns that go beyond the issue at hand."