March 12, 2020 / 6:51 PM / 24 days ago

BRIEF-FDA Is Informing Of Potential Risk Of Infections With Use Of Fecal Microbiota For Transplantation

March 12 (Reuters) - FDA

* FDA - INFORMING OF POTENTIAL RISK OF SERIOUS OR LIFE-THREATENING INFECTIONS WITH USE OF FECAL MICROBIOTA FOR TRANSPLANTATION

* FDA - AWARE OF INFECTIONS CAUSED BY ENTEROPATHOGENIC ESCHERICHIA COLI, SHIGATOXIN-PRODUCING ESCHERICHIA COLI THAT OCCURRED POST INVESTIGATIONAL FMT USE

* FDA- NOTIFIED OF 6 PATIENTS WHO GOT CO’S FMT PRODUCT FOR CLOSTRIDIUM DIFFICILE INFECTION NOT RESPONSIVE TO STANDARD THERAPIES

* FDA - CO NOTIFIED THE FDA OF TWO PATIENTS WHO DIED FOLLOWING RECEIPT OF FMT PRODUCT FROM THE DONOR ASSOCIATED WITH THE STEC INFECTIONS

* FDA - IT IS NOT KNOWN IF STEC INFECTION CONTRIBUTED TO TWO PATIENTS DEALTH FOLLOWING RECEIPT OF FMT PRODUCT

* FDA- 4 OF 6 PATIENTS WHO GOT CO’S FMT PRODUCT FOR CLOSTRIDIUM DIFFICILE INFECTION NEEDED HOSPITALIZATION Source text for Eikon:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below