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Food and Drug Administration (FDA) warning about biotin interference in laboratory tests

By: Rizwan Atiq, PharmD Candidate c/o 2019

Biotin is a nutrient that is present in certain foods and is available as a dietary supplement. It is present in many multivitamins as well as sold as its own supplement in pharmacies and supermarkets. It is marketed as a vitamin which is used to improve the health of hair, skin, and nails. The recommended daily intake of biotin is approximately 30 mcg.1

In November of 2017, the Food and Drug Administration (FDA) released a warning which put biotin under surveillance. The FDA warning stated that biotin can considerably interfere with certain lab tests and cause incorrect results which have the potential to go unnoticed by laboratories and healthcare professionals. Inaccurate test results may lead to inappropriate patient care or even a misdiagnosis. One lab value that biotin interferes with is troponin. A patient’s troponin level is an important biomarker in the diagnosis of a heart attack and a falsely low level may lead to a misdiagnosis. Lab tests such as cardiovascular diagnostic tests and hormone tests utilize biotin assays, therefore, these tests may yield inaccurate results if the patient is consuming excess biotin.2

In July of 2018, a case report was published by Köhler and colleagues in Deutsches Ärzteblatt International which discussed a 47-year-old man with multiple sclerosis who presented to his physician’s office for a routine follow up for a change in his drug therapy. During the follow-up he was found to have hyperthyroidism with positive thyroid-specific autoantibodies – a diagnosis which was made based on an immunoassay that utilizes streptavidin-biotin interactions to detect specific proteins and nucleic acids that are associated with disease state abnormalities. The patient was asymptomatic and his increased thyroid laboratory finding was not correlated with any clinical abnormality, thus, no treatment for hyperthyroidism was initiated. However, upon further questioning, it was found that the patient had been taking 300 mcg of biotin daily. The clinical team then performed another non-biotin related lab test to determine the patient’s thyroid levels which yielded normal findings that were consistent with his asymptomatic presentation. This case supports the FDA’s warning regarding discrepancies in laboratory results that may be due to biotin interference with diagnostic tests.3

There are some precautions health care providers can take to help prevent errors involving biotin from occurring. Patient education is an important factor. Health care providers should talk to their patients about any biotin supplements they may be taking, including supplements marketed for hair, skin, and nail growth, and explain that biotin has the potential to interfere with lab results that may be necessary for a life-saving diagnosis.  Communication between healthcare providers and laboratories is also important. Laboratories should be made aware of which patients are taking biotin supplementation.

The FDA is currently monitoring reports of adverse events associated with biotin interference in laboratory tests through MedWatch, an agency specific adverse event reporting program.2 Pharmacists can play a key role in preventing potential errors by educating and counseling patients and their physicians. Many patients purchase over-the-counter supplements, including biotin, at their pharmacies. When a patient purchases the supplement, pharmacists should counsel them to notify their doctors that they are taking biotin supplements as well as inform them of the potential interference with certain lab values.

SOURCES:

  1. Office of Dietary Supplements – Biotin. NIH Office of Dietary Supplements. https://ods.od.nih.gov/factsheets/Biotin-Consumer/. Published 12/08/2017. Accessed 05/23/2018.
  2. Biotin (Vitamin B7): Safety Communication – May Interfere with Lab Tests [FDA Safety Communication]. Gaithersburg, MD. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586641.htm Posted and accessed 05/20/2018.
  3. Köhler VF, Mann U, Mann WA. Biotin Interference in the Measurement of Thyroid Hormone. Dtsch Arztebl Int. 2018;115(29-30):500. doi: 10.3238/arztebl.2018.0500.

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