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.

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