FDA Reminds Clinicians About Biotin Interference With Troponin Tests

The agency created a new website to list assays that remain vulnerable to the issue.

The US Food and Drug Administration is reminding the medical community about the potential for high levels of biotin—or vitamin B7—to interfere with certain lab tests, including cardiac troponin assays.

On Tuesday, the agency issued an update to its 2017 safety communication warning that lab test results could be skewed in patients taking high levels of biotin, which is found in certain multivitamins and supplements aimed at improving hair, skin, and nail growth.

Since the initial safety communication, the makers of some cardiac troponin assays have addressed the interference issue, while others have not. The FDA has created a new website listing troponin assays that remain susceptible to biotin interference.

“The FDA wants to make the public and healthcare providers aware about biotin interference with lab tests so that patients, physicians, and laboratories can work together to help prevent adverse events,” the agency said in its update, noting that reports related to the issue continue to come in.

Though biotin interference can cause either falsely high or falsely low results on cardiac troponin testing, the FDA indicated that it’s particularly concerned with the latter because of the potential for missed MI diagnoses.

The agency’s initial 2017 safety communication came after a report that a patient who was taking high levels of biotin died following low troponin test results on an assay vulnerable to biotin interference.

The recommended daily allowance for biotin is 0.03 mg, an amount that doesn’t usually interfere with lab tests, but certain multivitamins and supplements can contain up to 100 mg of biotin per pill, the FDA explained. In addition, patients with certain conditions, like multiple sclerosis, may be instructed to take up to 300 mg of biotin a day.

“Sufficient information is not available to know if stopping biotin consumption for any number of hours prior to testing will prevent incorrect test results,” the FDA said.

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