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The United States Food and Drug Administration (FDA) warns health care providers and patients that fecal microbiota for transplantation (FMT) can transmit multidrug-resistant organisms, resulting in serious or life-threatening infections.
In a safety communication released today, the FDA has stated that two immunosuppressed adults who have received an FMT have developed invasive bacterial infections caused by extended-spectrum beta-lactamase (ESBL). Escherichia coli. One of the patients is dead.
The FMTs used in these two individuals were prepared from stool from the same donor. The donor stool and the resulting FMT used in these two individuals were not tested for the presence of ESBL-producing gram-negative organisms prior to their use, the FDA said.
After the occurrence of these infections, stored FMT preparations from this stool donor tested positive for ESBL production. E. coli identical to the isolated organisms of both patients.
Based on these two cases, the FDA recommends that, during any experimental use of the FMT, donors be screened with questions that specifically address risk factors for colonization by multidrug-resistant organisms. Individuals at higher risk of colonization by MDROs should be excluded.
Risk of unapproved treatment
The FDA also recommends that donor stools be tested for MDROs and that stool that is positive for MDROs be excluded.
"While we support this area of scientific discovery, it is important to note that the FMT is not without risk," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, in a press release.
"We have become aware of infections caused by multidrug-resistant microorganisms after patients have received an experimental FMT, including one death, so we want to alert all health professionals who administer the FMT to this potential risk. serious so that they can inform their patients "says Marks.
"Although the FDA does not approve the use of FMT, the agency plays a vital role in supporting product development while badessing the risks and benefits to patients of unapproved treatments. The agency is also striving to strike a balance between patient safety and ease of access. " unapproved treatments for unmet medical needs, "he added.
In 2013, the FDA issued guidelines in which it indicated its intention to exercise limited enforcement discretion with respect to the requirements for new investigational drugs for the FMT. used to treat Clostridium difficile infection in patients for whom standard therapies fail.
The TMF guidelines require that treating physicians obtain adequate informed consent, which must include a statement indicating that the use of TMF to treat it's hard is experimental and that doctors discuss potential risks with patients.
Adverse events badociated with the FMT should be reported to the FDA MedWatch Adverse Events Reporting Program.
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