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Biotin (Vitamin B7) can significantly interfere with
certain lab tests and cause incorrect test results
which may go undetected.
The FDA is alerting the public, health care
providers, lab personnel, and lab test developers
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.
Biotin (Vitamin B7) is a water-soluble vitamin often
found in multi-vitamins, prenatal vitamins, and
dietary supplements marketed for hair, skin, and
nail growth.
Many dietary supplements contain biotin levels up to
650 times the recommended daily intake of biotin.
The FDA has seen an increase in the number of
reported adverse events, including one death,
related to biotin interference with lab tests.
Biotin in patient samples can cause falsely high or
falsely low results, 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 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.
Physicians may also be recommending high levels of
biotin for patients with certain conditions such as
multiple sclerosis (MS).
Even physicians who are aware of this interference
are likely unaware as to whether, and how much
biotin, patients are taking.
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).
Many lab tests use biotin technology due to its
ability to bond with specific proteins which can be
measured to detect certain health conditions.
For example, biotin is used in hormone tests and
tests for markers of cardiac health like troponin.
Recommendations for Health Care Providers:
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.
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.
Report 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.
Recommendations for Lab Personnel:
If you use assays with biotin technology, be aware
that it is difficult to identify samples that
contain biotin; therefore, it is important to
communicate with health care providers and patients
to prevent incorrect test results.
If you are collecting samples in the lab, ask
whether the patient is taking biotin.
Educate health care providers about biotin
interference with certain lab tests used in your
lab.
Consider that the daily recommended allowance for
biotin is 0.03 mg and these biotin levels do not
typically cause significant interference.
However, supplements containing high biotin levels
including those marketed for hair, skin, and nail
benefits, may contain up to 20 mg of biotin, and
physicians may recommend up to 300 mg per day for
conditions such as multiple sclerosis.
Biotin levels higher than the recommended daily
allowance may cause significant interference with
affected lab tests.
Be aware that specimens collected from patients
taking high levels of biotin may contain more than
100 ng/mL biotin.
Concentrations of biotin up to 1200 ng/mL may be
present in specimens collected from patients taking
up to 300 mg per day.
Currently available data is insufficient to support
recommendations for safe testing using affected
tests in patients taking high levels of biotin,
including about the length of time for biotin
clearance from the blood.
Communicate with the lab test manufacturer if you
have questions about biotin interference.
Recommendations for Consumers:
Talk to your doctor if you are currently taking
biotin or are considering adding biotin, or a
supplement containing biotin, to your diet.
Know that biotin is found in multivitamins,
including prenatal multivitamins, biotin
supplements, and supplements for hair, skin, and
nail growth in levels that may interfere with
laboratory tests.
upplements, particularly those labeled for hair,
skin, and nail benefits, may have high levels of
biotin, which may not be clear from the name of the
supplement.
If you have had a lab test done and are concerned
about the results, talk to your health care provider
about the possibility of biotin interference.
Healthcare professionals and patients are encouraged
to report adverse events or side effects related to
the use of these products to the FDA's MedWatch
Safety Information and Adverse Event Reporting
Program.
For more information
U.S. Food and Drug Administration
Link...
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