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[Posted 06/18/2019]
Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms (3)
UDIENCE: Patient, Healthcare Professional
3. All FMT products currently in storage for which the donor has not undergone screening and stool testing for MDROs as described above must be placed in quarantine until such time as the donor is confirmed to be not at increased risk of MDRO carriage and the FMT products have been tested and found negative. In the case of FMT products manufactured using pooled donations from a single donor, stored samples of the individual donations prior to pooling must be tested before the FMT products can be administered to subjects.
4. The informed consent process for subjects being treated with FMT product under your IND going forward should describe the risks of MDRO transmission and invasive infection as well as the measures implemented for donor screening and stool testing.
FDA may consider alternative proposals that achieve equivalent risk mitigation as the measures outlined above.
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
3. 目前存放的所有FMT產品，如捐贈者未經過如上所述的MDRO篩檢和糞便檢測，必須進行檢疫，直到確認捐贈者沒有攜帶MDRO之高風險和FMT產品經過測試為MDRO陰性為止。
4. 在IND下接受FMT產品治療的受試者其知情同意應包含說明MDRO傳播和侵入性感染的風險及捐贈者篩檢和糞便檢測所採取的措施。
FDA可能會考慮可與上述措施相同可降低風險的替代方案。
相關訊息與連結請參考FDA網址：
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
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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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