After reports of serious, antibiotic-resistant infections linked to fecal transplants -- including one death -- the FDA wants to alert health care professionals of the risks.
But every therapy comes with risks, and the FDA said that two patients who received fecal microbiota transplants as part of a
developed life-threatening infections from multidrug-resistant bacteria delivered in the transplants. One of the patients has died. Both patients had weakened immune systems, making them more vulnerable to germs that are resistant to multiple . So, the FDA is now mandating that special screening and testing of the stool used in these procedures be done, to ensure that no drug-resistant bacteria are in the donated material.Also, when fecal microbiota transplants are used, doctors need to have adequate informed consent from the patient, the FDA said. Patients need to be warned of any potential risks associated with the treatment and be told that the treatment is still considered experimental.
To that end,"we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise," Marks said.Copyright © 2013-2018 HealthDay. All rights reserved.
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