FDA warns of one death linked to fe­cal trans­plants

The FDA on Thurs­day warned med­ical and sci­en­tif­ic com­mu­ni­ties and oth­er in­ter­est­ed per­sons of the po­ten­tial risk of trans­mit­ting mul­ti-drug re­sis­tant or­gan­isms (MDROs) via poop trans­plants, oth­er­wise known as fe­cal mi­cro­bio­ta for trans­plan­ta­tion (FMT).

FMT is typ­i­cal­ly used to help pa­tients with the bac­teri­um Clostrid­i­um dif­fi­cile who are not re­spond­ing to stan­dard ther­a­pies. 2013 guid­ance from the FDA re­vealed that the agency in­tends to ex­er­cise en­force­ment dis­cre­tion pro­vid­ed that the treat­ing physi­cian ob­tains ad­e­quate con­sent for the use of FMT from the pa­tient or his or her legal­ly au­tho­rized rep­re­sen­ta­tive. The con­sent should in­clude, at a min­i­mum, a state­ment that the use of FMT to treat C. dif­fi­cile is in­ves­ti­ga­tion­al and a dis­cus­sion of its po­ten­tial risks.

“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,” the agency said Thurs­day.

The FMT used in these two in­di­vid­u­als were pre­pared from a stool ob­tained from the same donor, al­though nei­ther the donor stool nor the re­sult­ing FMT was 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,” the FDA said.

Open­bio­me, a non­prof­it stool bank based in Cam­bridge, MA, told Fo­cus: “We are sad­dened to hear of the re­cent pa­tient death due to an in­fec­tion from a mul­ti-drug re­sis­tant or­gan­ism (MDRO) trans­mit­ted through a fe­cal trans­plant. Open­Bio­me ma­te­r­i­al was not in­volved. Open­Bio­me screens its donors and fe­cal trans­plant ma­te­r­i­al for MDROs and re­lat­ed risk fac­tors, and this se­ri­ous event fur­ther high­lights the im­por­tance of rig­or­ous screen­ing and clin­i­cal over­sight for all fe­cal trans­plant pro­ce­dures.”

Mov­ing for­ward, the FDA un­veiled two new pro­tec­tions nec­es­sary for any in­ves­ti­ga­tion­al use of FMT:

  • “Donor screen­ing with ques­tions that specif­i­cal­ly ad­dress risk fac­tors for col­o­niza­tion with MDROs, and ex­clu­sion of in­di­vid­u­als at high­er risk of col­o­niza­tion with MDROs.
  • MDRO test­ing of donor stool and ex­clu­sion of stool that tests pos­i­tive for MDRO. FDA sci­en­tists have de­ter­mined the spe­cif­ic MDRO test­ing and fre­quen­cy that should be im­ple­ment­ed.”

Safe­ty Alert

First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

Im­age: An­drew Harnik, AP



Zachary Brennan

managing editor, RAPS

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