FDA Issues Safety Alert Regarding Fecal Transplantation

On June 13, 2019, the FDA issued a safety alert in which it stated, in part, “The Food and Drug Administration (FDA) is informing health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). The agency is now aware of bacterial infections caused by multi-drug resistant organisms (MDROs) that have occurred due to transmission of a MDRO from use of investigational FMT.”

The safety alert was issued as a result of two immunocompromised adults who received investigational FMT who developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli). One of these individuals died. FMT used in these two individuals were prepared from stool obtained from the same donor. The donor stool and resulting FMT used in these two individuals were not 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.

In July 2013, the FDA issued guidance stating that it intends to exercise enforcement discretion under limited conditions regarding the IND requirements [Investigational New Drug requirements, see 21 CFR Part 312] for the use of FMT to treat Clostridium difficile (C. difficile) infection in patients who have not responded to standard therapies. The guidance states that the FDA 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 FDA stated that 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.

Because of the serious adverse reactions experienced by the two immunocompromised adults that occurred with investigational FMT, the FDA determined that the following protections are needed 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.

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The FDA’s nonbinding recommendations published in 2013 entitled “Guidance for Industry” stated, in part, “Fecal microbiota collected from healthy individuals are being investigated for use in the treatment of C. difficile infection. Published data suggest that the use of fecal microbiota to restore intestinal flora may be an effective therapy in the management of refractory C. difficile infection. However, the efficacy and safety profiles of this intervention have not yet been fully evaluated in controlled clinical trials … [the] FDA intends to exercise this discretion [regarding the IND requirements for the use of FMT to treat C. difficile infection not responding to standard therapies] provided that the treating physician obtains adequate informed consent from the patient or his or her legally authorized representative for the use of FMT products. Informed consent should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational and a discussion of its potential risks.”

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This entry was posted on Wednesday, August 7th, 2019 at 5:21 am. Both comments and pings are currently closed.

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