FDA: Vitamin B7 may interfere with lab tests

The FDA recently issued a safety communication regarding biotin, warning that it can “significantly interfere with certain lab tests,” and lead to incorrect lab results that can go unnoticed.

The agency stated there has been an increase in the number of reported adverse events among those taking biotin, also known as vitamin B7. The agency also said it has received a report that a patient who ingested high levels of biotin died following falsely low troponin test results when a troponin test known to have biotin interference was used.

Biotin is frequently found in dietary supplements that claim nail, skin and hair benefits, with many of these supplements containing biotin levels up to 650 times the daily recommended intake. Some physicians also recommend high levels of biotin for patients with multiple sclerosis, according to the FDA.

The FDA issued these recommendations for health care providers:

Talk to patients about any biotin supplements they may be ingesting.
Note that many lab tests, including but not limited to cardiovascular diagnostic tests and hormone tests, that use biotin technology are possibly affected, and incorrect test results may result if there is biotin in the patient’s specimen.
Let the lab conducting the testing know if a patient is taking biotin.
Consider biotin interference as a possible source for the error if a lab test result is inconsistent with the patient’s clinical presentation.
Notify the FDA and lab test manufacturer of patients experiencing an adverse event following potentially incorrect laboratory test results due to biotin interference.

“The FDA is working with stakeholders to better understand biotin interference with laboratory tests, and to develop additional future recommendations for safe testing in patients who have taken high levels of biotin when using laboratory tests that use biotin technology,” the agency said. “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.”

For more information: FDA. “The FDA warns that biotin may interfere with lab tests: FDA safety communication.” https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm586505.htm. Accessed Nov. 28, 2017.