FDA Warns About Potential Vitamin Interference With Lab Tests

NOVEMBER 28, 2017
Officials with the FDA are warning the public that biotin, or vitamin B7 can significantly interfere with certain lab tests and cause "clinically significant incorrect lab test results." At least 1 death has been related to biotin interference with laboratory results, FDA officials wrote in a Safety Alert. 

Incorrect test results may lead to inappropriate patient management or misdiagnosis, and the adminstration pointed to a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, as an example of something that may lead to a missed diagnosis. FDA officials received a report that 1 patient taking high levels of biotin died following falsely low troponin test results when a troponin test known to have biotin interference was used.

Officials with the FDA noted that dietary supplements that contain high biotin levels are often promoted for hair, skin, and nail benefits. Physicians may also be recommending high levels of biotin for patients with certain conditions such as multiple sclerosis (MS). 

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.

In the interim, FDA officials are urging health care providers to discuss biotin supplement use with patients, and to remain aware of what supplements contain biotin and to discuss the potential for laboratory interference with patients.

Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests [FDA Safety Communication]. Gaithersburg, MD. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586641.htm Posted and accessed Nov. 28, 2017.