The US Food and Drug Administration (FDA) is updating its 2017 safety communication to remind the public, health care providers, lab personnel, and lab test developers that biotin, often found in dietary supplements, can significantly interfere with certain lab tests and cause incorrect results that may go undetected. The FDA wants to make the public and health care providers aware about biotin interference with lab tests so that patients, physicians, and laboratories can work together to help prevent adverse events.
As noted in the original safety communication, while biotin in patient samples can cause falsely high or falsely low results, depending on the type of test, the FDA is particularly concerned about biotin interference causing a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, which may lead to a missed diagnosis and potentially serious clinical implications. The FDA continues to receive adverse events reports indicating biotin interference caused falsely low troponin results.
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. The FDA remains concerned about troponin laboratory tests that have not addressed the risk of biotin interference. The FDA has posted a webpage on “Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference” to notify the public about troponin assays where the risk of biotin interference has not yet been addressed.
Consumers are recommended:
- Talk to their doctor if they are currently taking biotin (also called vitamin B7) or are considering adding biotin, or a supplement containing biotin, to their diet.
- Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and supplements for hair, skin, and nail growth in levels that may interfere with laboratory tests. However, the amount of biotin can vary significantly among different products. Consider that the daily recommended allowance for biotin is 0.03mg and that amount does not typically cause interference in lab tests.
- Be aware that some supplements, particularly those labeled to benefit hair, skin, and nails, may have high levels of biotin, which may not always be clear from the name of the supplement. FDA is aware of many supplements containing 20mg of biotin, and some containing up to 100mg per pill, with recommendations to take multiple pills per day. Supplements containing high biotin levels may interfere with affected lab tests.
- Sufficient information is not available to know if stopping biotin consumption for any number of hours prior to testing will prevent incorrect test results.
- If they had a lab test done and are concerned about the results, talk to their health care provider about the possibility of biotin interference.
Health care providers are recommended:
- Talk to their patients about any biotin supplements or multivitamin supplements they are taking that may contain biotin, including supplements marketed for hair, skin, and nail growth.
- Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth in levels that may interfere with lab tests.
- Be aware that many lab tests, including but not limited to cardiovascular diagnostic tests and hormone tests, that use biotin technology are potentially affected, and incorrect test results may be generated if there is biotin in the patient's specimen.
- Communicate to the lab conducting the testing if their patient is taking biotin.
- If a lab test result does not match the clinical presentation of their patient, consider biotin interference as a possible source of error.
- Report to the lab test manufacturer and the FDA if they become aware of a patient experiencing an adverse event following potentially incorrect laboratory test results due to biotin interference.
Please refer to the following website in FDA for details:
http://www.fda.gov/medical-devices/safety-communications/update-fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication
In Hong Kong, there are 113 registered pharmaceutical products containing biotin. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to biotin. Related news was previously issued by FDA and Singapore Health Sciences Authority, and was posted on the Drug Office website on 29 Nov 2017, 28 May 2019 and 12 Sep 2019. Letters to inform local healthcare professionals were issued by the DH on 29 Nov 2017. The DH will notify the concerned lab parties and will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Nov 6, 2019
Issued at HKT 17:00
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