FDA Warns of Biotin Interference in Lab Assays

November 6, 2019

Could lead to falsely high or low results, especially troponin assays.

The FDA has updated their safety communication regarding the interference of Biotin in various lab test assays in response to continued reports of adverse events occurring as a result of incorrect and misleading results. 

In 2017, the FDA issued their first safety communication after receiving reports of adverse events and one death related to Biotin interference in lab test assays. 

Biotin, or Vitamin B7, is the water-soluble vitamin that is often found in multi-vitamins; prenatal vitamins; and dietary supplements marketed for hair, skin, and nail growth. In lab tests, the FDA says Biotin technology is used due to the vitamin’s ability to bond with specific proteins that are subsequently measured to detect health conditions.

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In its original safety communication, the FDA says it is particularly concerned for the interference that results in falsely low levels of troponin-the biomarker that aids in diagnosis of heart attacks. Misleading diagnoses as a result of incorrect lab results could lead to potentially serious clinical implications, the FDA says. 

The FDA’s recommendations for healthcare providers:

  • Discuss biotin and multivitamin supplements with patients (including those for hair, skin, and nail growth)

  • Many lab tests are affected, including but not limited to cardiovascular diagnostic tests and hormone tests

  • Communicate with the lab conducting testing if patients are taking any biotin 

  • If lab test results do not match clinical presentation, consider biotin interference as a source of error

  • Report to the lab manufacturer and FDA if you become aware of patients experiencing an adverse event following potentially incorrect laboratory test results due to biotin interference

 

The FDA is also maintaining an updated list of assays subject to biotin interference on its website.