The FDA Safety Information and Adverse Event Reporting Program
: The FDA is 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.
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. The FDA has seen an increase in the number of reported adverse
events, including one death, related to biotin interference with lab tests.
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 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.
The FDA is
aware of people taking high levels of biotin that would interfere with lab
tests. Many dietary supplements promoted for hair, skin, and nail benefits
contain biotin levels up to 650 times the recommended daily intake of biotin.
Biotin levels higher than the recommended daily allowance may cause
interference with lab tests.
The FDA is
monitoring reports of adverse events associated with biotin interference with
laboratory tests and will update the public if significant new information
to your doctor if you are currently taking biotin or are considering
adding biotin, or a supplement containing biotin, to your diet.
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.
aware that some supplements, 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.
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.
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:
Read the MedWatch Safety Alert, including a link
to the FDA Safety Communication.
and submit the report Online:
or call 1-800-332-1088 to
request a reporting form, then complete and return to the address on the
pre-addressed form, or submit by fax to 1-800-FDA-0178