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:
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。