News Release

Biotin supplements caused misleading test results, almost led to unnecessary procedure

FDA issued warning about biotin interference with lab tests in November 2017

Peer-Reviewed Publication

University of North Carolina Health Care

Maya Styner, M.D., University of North Carolina Health Care

image: This is Maya Styner, M.D., Associate Professor, University of North Carolina School of Medicine. view more 

Credit: © UNC School of Medicine

May 18, 2018 - A new case report in the Journal of the Endocrine Society documents how a patient's use of a common biotin supplement, also known as vitamin B7, caused her to have clinically misleading test results, which prompted numerous consultations and unnecessary radiographic and laboratory testing.

The patient in the case report took a 5000 mcg dose of biotin daily. Biotin supplements in that dosage are commonly sold over-the-counter, without a prescription, in many grocery and drug stores for about $8-$20 a bottle. They are marketed as being good for healthy hair, skin and nails, but there is no scientific evidence to support this claim.

In this patient's case, "The negative clinical impact included weeks of psychological distress concerning the possibilities of hypercortisolemia or a testosterone-producing tumor. Most significantly, these abnormal test results nearly resulted in an unnecessary invasive procedure for a complex patient with a hypercoagulable state," the case report says. Hypercortisolemia is a condition involving a prolonged excess of cortisol -- a steroid hormone -- in blood.

Maya Styner, MD, associate professor of endocrinology and metabolism in the department of medicine, is the case report's corresponding author.

"The literature is lacking with regard to biotin interference with serum cortisol and testosterone immunoassays, as in our case-report," Styner said. "Patients are ingesting supplements in a higher frequency, and higher doses, and therefore this case is timely and relevant from both a clinical and basic-science perspective."

She added, "Our manuscript is a product of a collaboration between endocrinology, reproductive endocrinology/gynecology and clinical chemistry at UNC and at the Mayo Clinic. This collaboration enabled us to ascertain the underlying diagnosis and perform relevant research-based biotin quantification in our patient's sample."

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Co-authors of the case report are Heather M. Stieglitz, PhD, Nichole Korpi-Steiner, PhD, Brooke Katzman, PhD and Jennifer E. Mersereau, MD. All are at UNC except for Katzman, who is co-director of the Hospital Clinical Laboratory and Point of Care, at the Mayo Clinic in Rochester, Minnesota.

In November 2017, the U.S. Food & Drug Administration issued a warning "alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected."


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