Devices

Safety Alert on Biotin Affecting Lab Testing

An FDA safety alert warns that dietary supplements containing biotin (vitamin B7) can cause clinically significant incorrect lab test results. The agency says it is seeing an increase in 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,” it says. “Incorrect test results may lead to inappropriate patient management or misdiagnosis. For example, a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, 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.”

Many dietary supplements advertised for hair, skin, and nail improvements contain biotin levels up to 650 times the recommended daily intake, the alert says. Sometimes, physicians may recommend biotin for patients with certain conditions such as multiple sclerosis. Biotin levels higher than the recommended daily allowance may cause interference with lab tests, it says.

The alert recommends that healthcare providers discuss with patients any biotin supplements they may be taking. They should also communicate to lab personnel if a patient is taking biotin.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome