◎Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests
AUDIENCE: Laboratory, Health Professional, Patient
ISSUE: The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.
Biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results. The FDA has seen an increase in the number of 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. 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.
The FDA is aware of people taking high levels of biotin that would interfere with lab tests. Many dietary supplements promoted for hair, skin, and nail benefits contain biotin levels up to 650 times the recommended daily intake of biotin. Physicians may also be recommending high levels of biotin for patients with certain conditions such as multiple sclerosis (MS). Biotin levels higher than the recommended daily allowance may cause interference with lab tests.
Patients and physicians may be unaware of biotin interference in laboratory assays. Even physicians who are aware of this interference are likely unaware as to whether, and how much biotin, patients are taking. Since patients are unaware of biotin interference, patients may not report taking biotin supplements to their physicians, and may even be unware they are taking biotin (e.g., when taking products generally labeled for their benefits to hair and nails).
The FDA is working with stakeholders to better understand biotin interference with laboratory tests, and to develop additional future recommendations for safe testing in patients who have taken high levels of biotin when using laboratory tests that use biotin technology.
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.
Biotin（生物素），又名維生素B7，為水溶性，常見於綜合維他命、產前孕婦需補充的維他命、標榜對於頭髮、皮膚、指甲生長有好處的營養補充品中。很多檢驗項目可能會使用biotin科技，藉由biotin與特殊蛋白質鍵結的特性，以測量健康狀態。例如：biotin可用於荷爾蒙檢驗或心臟相關檢驗（測量troponin(心肌肌鈣蛋白)）。
美國FDA發布相關警訊提醒大眾、醫療專業人員、檢驗人員、以及開發檢驗方法之相關人員，病人若服用高單位biotin的營養補給品，其病人檢體中的biotin可能顯著干擾檢驗結果，根據不同的檢驗項目，可能會造成誤判檢驗數值太高或太低，導致檢驗結果不正確。不正確的檢驗結果可能導致病人後續的診斷或處置不適當。例如：誤判troponin數值低，可能無法診斷出心臟病相關問題(heart attacks)。美國FDA接獲通報，關於一名病人服用高單位的biotin，因biotin干擾檢驗數值，無法正確判讀troponin的檢驗數值而死亡。
美國FDA提醒，許多營養補充品含高於每日建議量650倍之biotin，宣稱對頭髮、皮膚和指甲有好處，醫師也可能會建議高單位biotin於某些特殊疾病的病人，例如：多發性硬化症(multiple sclerosis)。然而服用高於每日建議量之高單位biotin可能會干擾部分檢驗項目之數值正確的判讀。
病人或醫師可能不清楚高單位biotin可能會干擾部分檢驗數值，即使醫師知道高單位biotin會干擾檢查，可能也無法得知病人有服用或服用多少含量的biotin；病人若不清楚biotin會造成檢驗的干擾，可能也不會跟醫師回報有服用biotin，或產品未標示含biotin，僅標示對頭髮和指甲有好處。因此，未來關於服用高單位含量的biotin病人，其相關檢驗項目及判讀的建議，美國FDA及相關業者正在研擬中。美國FDA也會持續監測與biotin干擾檢驗數值有關的不良反應報告，並持續更新相關資訊。
相關訊息與連結請參考FDA網址：https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586641.htm
（待續）
[Posted 11/28/2017]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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