藥物警訊

Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests（續上期）
BACKGROUND: Many lab tests use biotin technology due to its ability to bond with specific proteins which can be measured to detect certain health conditions. For example, biotin is used in hormone tests and tests for markers of cardiac health like troponin. Biotin, also known as vitamin B7, is a water-soluble vitamin often found in multi-vitamins, prenatal vitamins, and dietary supplements marketed for hair, skin, and nail growth.
RECOMMENDATIONS:
For Health Care Providers:
• Talk to your patients about any biotin supplements they may be taking, including supplements marketed for hair, skin, and nail growth.
• 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 your patient is taking biotin.
• If a lab test result doesn't match the clinical presentation of your patient, consider biotin interference as a possible source of error.
• 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.
• Report to the lab test manufacturer and the FDA if you become aware of a patient experiencing an adverse event following potentially incorrect laboratory test results due to biotin interference.
For Lab Personnel:
• If you use assays with biotin technology, be aware that it is difficult to identify samples that contain biotin; therefore, it is important to communicate with health care providers and patients to prevent incorrect test results.
• If you are collecting samples in the lab, ask whether the patient is taking biotin.
• Educate health care providers about biotin interference with certain lab tests used in your lab.
• Consider that the daily recommended allowance for biotin is 0.03 mg and these biotin levels do not typically cause significant interference. However, supplements containing high biotin levels including those marketed for hair, skin, and nail benefits, may contain up to 20 mg of biotin, and physicians may recommend up to 300 mg per day for conditions such as multiple sclerosis. Biotin levels higher than the recommended daily allowance may cause significant interference with affected lab tests.
• Be aware that specimens collected from patients taking high levels of biotin may contain more than 100 ng/mL biotin. Concentrations of biotin up to 1200 ng/mL may be present in specimens collected from patients taking up to 300 mg per day.
• Currently available data is insufficient to support recommendations for safe testing using affected tests in patients taking high levels of biotin, including about the length of time for biotin clearance from the blood.
• Communicate with the lab test manufacturer if you have questions about biotin interference.
For Consumers:
• Talk to your doctor if you are currently taking biotin or are considering adding biotin, or a supplement containing biotin, to your 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.
• Be aware that some supplements, particularly those labeled for hair, skin, and nail benefits, may have high levels of biotin, which may not be clear from the name of the supplement.
• If you have had a lab test done and are concerned about the results, talk to your health care provider about the possibility of biotin interference.
Read the MedWatch Safety Alert, including a link to the FDA Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586641.htm
對於醫療專業人員之建議：
1. 詢問病人是否正在服用含biotin之營養補充品，包含對頭髮、皮膚、指甲生長有好處的補充品或綜合維他命等等。
2. 許多檢驗項目可能會被病人檢體所含之biotin所影響，包含心血管相關的檢測或荷爾蒙檢驗，而導致錯誤的判讀檢驗數值。
3. 若病人正在服用biotin，請與檢驗單位溝通。
4. 如果檢驗數值與病人的臨床表徵不符合，請把biotin的干擾納入考量。
5. 若得知病人因biotin干擾檢驗數值判讀，而導致出現不良反應，請回報給美國FDA及相關檢驗項目之廠商。
對於檢驗相關人員：
1. 如果檢驗方法使用biotin科技，含biotin的檢體很難正確判讀數值，請與醫療專業人員以及病人確認，以避免錯誤判讀。
2.	若檢體是由實驗室收集而來，請與病人確認是否有在服用biotin。
3. 教育醫療專業人員，關於服用biotin對某些檢驗可能造成干擾。
4. 每日建議補充之biotin含量為0.03 mg，此含量並不會顯著影響檢驗數值。然而標榜對頭髮、皮膚以及指甲有好處的之營養補充品，可能含超過20 mg之biotin，或醫師可能會建議多發性硬化症之病人每日服用300 mg之biotin，遠高於每日建議補充量之biotin可能會顯著影響檢驗結果。
5. 使用高單位biotin之病人檢體，其內含biotin濃度可能超過100 ng/mL，每日服用300 mg之biotin，其檢體含biotin之濃度更高達1200 ng/mL。
6. 目前尚無服用高單位biotin病人其安全檢驗的相關建議，包含病人血中biotin清除率時間。
7. 若對於biotin的干擾有問題，請與檢驗的製造商連繫。
對於消費者使用建議：
1. 若您有在服用任何添加biotin的營養補充品或是健康食品，請告知醫師。
2. 綜合維他命或是對頭髮、皮膚以及指甲有好處的營養補充品可能包含Biotin（但不一定會清楚標示其含biotin）中，並可能干擾檢驗數值。
3. 若近期接受相關檢驗，且對檢驗數值有疑慮，請與醫療專業人員聯繫。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586641.htm
（全文完）
 [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