Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms (1)
UDIENCE: Patient, Healthcare Professional
ISSUE: The FDA is now aware of bacterial infections caused by multi-drug resistant organisms (MDROs) that have occurred due to transmission of a MDRO from use of investigational fecal microbiota for transplantation (FMT):
• Two immunocompromised adults who received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli). One of the individuals died.
－ FMT used in these two individuals were prepared from stool obtained from the same donor.
－ The donor stool and resulting FMT used in these two individuals were not tested for ESBL-producing gram-negative organisms prior to use. After these adverse events occurred, stored preparations of FMT from this stool donor were tested and found to be positive for ESBL-producing E. coli identical to the organisms isolated from the two patients.
Because these serious adverse reactions occurred with investigational FMT, FDA has determined that additional protections are needed for any investigational use of FMT. FDA has notified all Investigational New Drug (IND) holders of these requirements and that they need to implement these new requirements no later than July 15, 2019.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
美國FDA發現使用糞便微菌叢植入治療（fecal microbiota for transplantation, FMT）可能會傳播多重抗藥性細菌（multi-drug resistant organisms, MDROs），造成細菌感染。FMT研究發現2名免疫功能低下成人在接受FMT治療後出現廣效性β-內醯胺分解?(extended-spectrum beta-lactamase, ESBL)的大腸桿菌（Escherichia coli, E.coli）引發的侵襲性感染。其中一人死亡。
(2) 在進行FMT前，未對這兩人使用的捐贈者糞便和製備的FMT進行ESBL革蘭氏陰性菌進行檢驗。在發生不良事件後，檢驗該捐贈者糞便的FMT製劑，發現其為ESBL E.Coli陽性且與該兩名病人身上所分離出的菌種相同。
由於這些嚴重不良反應發生在FMT研究中，因此FDA已決定任何研究FMT治療都需要額外的保護措施。FDA已通知所有研究新藥（Investigational New Drug, IND）之公司需於2019年7月15日之前實施新做法。