Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms (2)
UDIENCE: Patient, Healthcare Professional
RECOMMENDATION: Patients considering FMT to treat C. difficile infection should speak to their health care provider to understand the potential risks associated with the product's use.
To ensure that all stakeholders are fully informed, FDA is providing the following information that has been communicated to IND holders:
1. Donor screening must include questions that specifically address risk factors for colonization with MDROs, and individuals at higher risk of colonization with MDROs must be excluded from donation. Examples of persons at higher risk for colonization with MDROs include:
a. Health care workers
b. Persons who have recently been hospitalized or discharged from long term care facilities
c. Persons who regularly attend outpatient medical or surgical clinics
d. Persons who have recently engaged in medical tourism
2. FMT donor stool testing must include MDRO testing to exclude use of stool that tests positive for MDRO. The MDRO tests should at minimum include extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae, vancomycin-resistant enterococci (VRE), carbapenem-resistant Enterobacteriaceae (CRE), and methicillin-resistant Staphylococcus aureus (MRSA). Culture of nasal or peri-rectal swabs is an acceptable alternative to stool testing for MRSA only. Bookend testing (no more than 60 days apart) before and after multiple stool donations is acceptable if stool samples are quarantined until the post-donation MDRO tests are confirmed negative.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/fecal-microbiota-transplantation-safety-communication-risk-serious-adverse-reactions-due?utm_campaign=FDA%20MedWatch%20Fecal%20Microbiota%20for%20Transplantation%3A%20Safety%20Communication&utm_medium=email&utm_source=Eloqua
建議：考慮使用FMT治療艱難梭菌(C. difficile)感染的病人應與其醫療照護之相關專業人員聯繫，以了解該產品使用之相關的潛在風險。FDA向IND公司要求的做法如下：
1. 捐贈者篩檢主要是針對MDRO移生風險因子評估，將具較高風險MDRO移生的人排除在捐贈者之外。MDRO移生風險較高的人包括：
a. 醫療人員
b. 長期照護機構住院中或剛從長期照護機構出院之病人
c. 定期回內科或外科門診就醫之病人
d. 最近於國外尋求醫療協助的人
2. FMT捐贈者糞便檢測必須包括MDRO檢驗，以排除使用對MDRO檢驗呈陽性的糞便。MDRO檢驗至少應包括ESBL E.coli、vancomycin-resistant enterococci (VRE)、carbapenem-resistant Enterobacteriaceae (CRE)和methicillin-resistant Staphylococcus aureus (MRSA)。捐贈者的鼻腔或直腸周圍拭子的培養僅可做為糞便檢驗是否有MRSA菌株的替代方案。糞便樣本需被隔離，直到捐獻後MDRO檢驗確認為陰性。
相關訊息與連結請參考FDA網址：http://t.cn/Aij2cUpd
（待續）
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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