News from the FDA/CDC

FDA still concerned about biotin affecting troponin tests


The Food and Drug Administration has issued another safety communication warning that biotin can significantly interfere with laboratory tests for troponin.

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However, not all troponin tests are affected, according to the update. “Since the FDA’s safety communication on this topic in 2017, some lab test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it,” according to the new communication, issued in early November.

Also known as vitamin B7 and appearing in many dietary supplements, including prenatal multivitamins and supplements for hair, skin, and nail growth, biotin can lead to falsely low results on some troponin tests, especially at high levels. The worry is that biotin interference could therefore lead to missed diagnoses. The FDA has provided a list of those tests that have not taken biotin’s effects into account, titled “Biotin Interference with Troponin Lab Tests – Assays Subject to Biotin Interference.”

The daily recommended allowance for biotin, according to the communication, is about 0.3 mg, but it isn’t always clear how much is actually included in supplements – some can contain 20 mg or even as much as 100 mg per pill of biotin. The communication includes recommendations for patients, health care professionals, laboratory personnel, and lab test manufacturers and developers.

The full safety communication can be found on the FDA website, and problems with tests can be reported via the FDA’s MedWatch Voluntary Reporting Form.

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