FDA is­sues an­oth­er safe­ty alert re­lat­ed to fe­cal trans­plants, as da­ta sug­gest coro­n­avirus lingers in poop

Since 2013, the FDA has im­ple­ment­ed a pol­i­cy of “en­force­ment dis­cre­tion” re­gard­ing fe­cal mi­cro­bio­ta trans­plants (FMT) to treat re­frac­to­ry C. diff: While bio­phar­ma com­pa­nies work on de­vel­op­ing stan­dard­ized prod­ucts, physi­cians can con­duct FMT’s af­ter se­cur­ing rea­son­able con­sent from pa­tients. But since last sum­mer, a hand­ful of safe­ty is­sues have caused a stir in the field.

Ear­li­er this week, the FDA is­sued a safe­ty alert high­light­ing the risk of po­ten­tial trans­mis­sion of the new coro­n­avirus from fe­cal mat­ter de­rived from donors used in FMT, and said that ad­di­tion­al safe­ty mea­sures are nec­es­sary.

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