In January 2017, the B vitamin biotin was in the news as a possible breakthrough treatment for multiple sclerosis (MS). This positive news was dampened a bit when the U.S. Food and Drug Administration (FDA) released a warning regarding the safety of biotin on November 28, 2017.1 The headlines generated from the FDA warning are a bit misleading as biotin is certainly safe, even at the massive doses being used in multiple sclerosis. The safety concern is that high dosages of biotin can significantly interfere with certain laboratory tests. This interference can lead to dangerously incorrect conclusions.
Several lab tests utilize biotin to bind to specific proteins in the blood that can then be measured to determine the diagnosis of cancer, heart disease, thyroid disorders, and even pregnancy. With high dosages, the presence of biotin in the blood can interfere with the test results causing either falsely low or high results, which can certainly be a problem.
The FDA is doing its job in alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests. While there are many valid points about the FDA warning, some perspective is required. Certainly, at the massive dosages being used in the medical treatment of MS (i.e., 300 mg per day), biotin interference is definitely going to be a problem. But, what about at dosages less than 10 mg per day?
The only real published data that has looked at this question was published in January 2017 in the Annals of Clinical Biochemisty.2 Here is what that study demonstrated. Yes, at 300 mg per day, there is significant interference in test results that could be a major issue. Physicians must be aware of this issue when prescribing such high dosages. But, at a dosage range of 5-10 mg of biotin there were only a few tests where interference was significant and it was based primarily on the test method.
There are different ways of measuring these proteins and interference is somewhat dependent on the method. For example, Roche immunoassays are particularly vulnerable while those from Siemens are not. The tests that showed the most concern at a dosage of 10 mg per day are those anti-thyroid antibodies used in the diagnosis of thyroid disease and troponin, a blood protein used to differentiate between an angina attack versus a myocardial infarction. The interference with troponin is a big concern because it may mean not getting the right diagnosis in an emergency situation with the patient being treated for angina instead of a heart attack.
Here are some takeaways for clinicians to consider:
- Know the level of biotin your patients are taking and keep in mind that biotin is not only available on its own as a supplement, but is also found in multivitamins and supplements for hair, skin, and nail health.
- Biotin at dosages greater than 5 mg may interfere with laboratory tests so be sure to carefully consider possible biotin interference. Talk to the lab to determine what methods of analysis were used and judge the appropriateness of retesting after washing out the biotin from your patient’s system. No supplementation for two weeks should be sufficient.
- Patients being treated for angina or thyroid disease taking dosages greater than 10 mg daily should be monitored carefully.
- While high dosages of biotin supplements lead to interference in laboratory tests, so do low levels of biotin in the blood. This problem has also not been fully defined. It may be that labs will need to factor in biotin levels when reporting any result from a test that uses biotin technology.
Biotin Use Guidelines
The estimated safe and adequate dietary intake of biotin for adults is 30-100 mcg. To promote stronger nails and healthy hair, a typical dosage range is 1,000 to 3,000 mcg per day. In the treatment of seborrheic dermatitis, the dosage to administer to nursing mothers is 3,000 mcg twice daily. For infants not being breast-fed, an effective dosage is estimated to be 100-300 mcg daily. In the treatment of diabetes and diabetic neuropathy, dosages of 4 to 8 mg twice daily have been used successfully.
Biotin is extremely safe and no side effects have ever been reported with biotin supplementation. That being said, individuals with diabetes should use caution when using high dosages (e.g., greater than 4 mg) as it may produce reductions in blood sugar levels requiring changes in the dosage of insulin or other medications.
As far as negative interactions, the biggest one is the problem with antibiotics. Since antibiotics may decrease biotin levels due to destruction of biotin-producing bacteria in the intestines, it is important to utilize probiotics during antibiotic use and supplement with at least the recommended dietary intake (RDI) for biotin. Alcohol also inhibits the absorption and utilization of biotin.
As for some positive interactions, biotin works synergistically with other B-vitamins as well as coenzyme Q10 and carnitine.
Biotin is an important nutrient that can be used successfully by clinicians when monitored appropriately.
- US Food & Drug Administration https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586641.htm
- Trambas C, Lu Z, Yen T, Sikaris K. Characterization of the scope and magnitude of biotin interference in susceptible Roche Elecsys competitive and sandwich immunoassays. Ann Clin Biochem. 2017;Jan 1.