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What The FDA Warns About Biotin Supplementation

In November 2017, the Food and Drug Administration (FDA) posted a communication about the issues with biotin and its effects on laboratory studies.1 At the most recent Council for Nail Disorders meeting in February 2018, many of the speakers drove this point home. Let’s dive into this topic.

Biotin is an over-the-counter supplement that many of us recommend for our patients with nail issues. Dermatologists also recommend it for hair and nails. However, biotin significantly interferes with laboratory studies, causing either a falsely high or low result depending on the test.1 Due to the lack of regulation of vitamins, patients may be taking 650 times the recommended daily dose of biotin in their daily supplements. The patients who are taking such high doses of biotin may have “clinically significant incorrect” lab results and there have been several reported adverse events, including one death.1 

Interestingly, biotin (or vitamin B7) is used in laboratory studies due to its ability to bind to specific proteins. For example, biotin is a part of the lab test for detection of troponin T, a marker of cardiac damage.1

Both patients and physicians may be unaware of the potential biotin interference in lab tests. Patients may not even realize that their “hair, skin and nails” supplement they bought at the drugstore contains higher than recommended doses of biotin or has biotin at all. They may not even report biotin supplementation to their physician, thinking it is irrelevant to their medication history. 

The FDA is working on understanding biotin interference in tests that use biotin-protein binding technology. It is also monitoring adverse event reports linked to biotin and lab assays.1

So what can we do as healthcare practitioners? The FDA recommends the following measures.1 

“Talk to your patients about any biotin supplements they may be taking, including supplements marketed for hair, skin, and nail growth. Be aware that many lab tests, including but not limited to cardiovascular diagnostic tests and hormone tests that use biotin technology, are potentially affected, and incorrect test results may be generated if there is biotin in the patient’s specimen.1

“Communicate to the lab conducting the testing if your patient is taking biotin. If a lab test result doesn’t match the clinical presentation of your patient, consider biotin interference as a possible source of error. Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth in levels that may interfere with lab tests.1

“Report both to the lab test manufacturer and the FDA if you become aware of a patient experiencing an adverse event following potentially incorrect laboratory test results due to biotin interference.”1

You can report an adverse event by visiting this website or the communication on biotin on the FDA’s website: www.fda.gov/MedWatch/report .

I stopped recommending biotin to patients years ago when I had patients complain of symptoms like acne and high blood pressure while on it. This FDA communication certainly fortifies the reason for my lack of use of biotin in my practice. 

Reference  

1. Food and Drug Administration. Biotin (vitamin B7): safety communication—may interfere with lab tests. Available at https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586641.htm . Published Nov. 28, 2017.

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