Biotin (Vitamin B7) - May Interfere with Lab Tests

Posted by GPWHC on 29 November 2017

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Release date 11/28/2017

ISSUE : 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.

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. 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 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 becomes available.

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.
  • Be 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.
  • 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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form 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
Read the MedWatch Safety Alert, including a link to the FDA Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586641.htm




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