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                Safety & Availability (Biologics)

Safety & Availability (Biologics)

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          Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation -- Testing of Stool Donors for Enteropathogenic Escherichia coli and Shigatoxin-Producing Escherichia coliSafety & Availability (Biologics) Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation -- Testing of Stool Donors for Enteropathogenic Escherichia coli and Shigatoxin-Producing Escherichia coli
  
  	
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    Print**April 6, 2020**

On March 12, 2020, The Food and Drug Administration (FDA) informed health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT).  Infections caused by enteropathogenic *Escherichia coli* (EPEC) and Shigatoxin-producing *Escherichia coli* (STEC) have occurred following investigational use of FMT for treatment of *Clostridium difficile* (also called *Clostridioides difficile* or *C. difficile*) infection not responsive to standard therapies. FDA suspects these infections are due to transmission of these pathogenic organisms from FMT product supplied by a stool bank company based in the United States.

After the release of FDA’s March 12, 2020, Safety Alert, the stool bank company publicly acknowledged FDA’s safety communication, so we are now identifying the stool bank as OpenBiome, a company based in Cambridge, Massachusetts.

Because of these serious adverse events that occurred with investigational FMT, FDA has determined that additional protections are needed for any investigational use of FMT, whether under an Investigational New Drug Application (IND) on file with the FDA or under FDA’s enforcement discretion policy.

FDA has already communicated with OpenBiome and individually with IND holders for investigational FMT to underscore the need for additional protections.  These additional protections include:

Testing FMT donor stool by nucleic acid amplification tests (NAAT) for EPEC and STEC to exclude use of stool that tests positive for either EPEC or STEC.
	Testing of stool from each donor before and after multiple stool donations, no more than 60 days apart; and, as applicable, quarantining FMT product lots manufactured from these donations until both pre- and post-donation EPEC and STEC tests are confirmed negative.
	Testing of all FMT products currently in storage for which the donor has not undergone stool testing for both EPEC and STEC using NAAT as described above.
	Until this testing is able to be completed, placing those FMT products in quarantine until they have been tested using NAAT and found negative for EPEC and STEC.
		In the case of FMT products manufactured using pooled donations from a single donor, performing stool testing on individual stool samples (not pooled) within the testing window described above for a given lot of FMT product.Patients considering FMT to treat *C. difficile* infection should speak to their health care provider to understand the potential risks associated with the product’s use.

FDA encourages all health care providers who have administered FMT products to their patients to report suspected adverse events to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

**Additional Resources:**

Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms – March 12, 2020

Update to March 12, 2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms– March 13, 2020

                                                                                  Content current as of:
      04/06/2020Safety & Availability (Biologics)

          
                        Biologic Product Security
          Blood Safety & Availability
          CBER-Regulated Products: Shortages and Discontinuations
          Pandemics & Emerging Diseases
          Tissue Safety & Availability
          Vaccine Safety & Availability


                        HIV Home Test Kits
          Recalls (Biologics)
          Report a Problem to the Center for Biologics Evaluation & Research
 
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