MEDFORD, Mass. — The biotech company OpenBiome, which specializes in collecting stool samples from donors to transplant into other people who need new bacteria in their guy, is the subject of a safety alert published by the U.S. Food and Drug Administration (FDA) recently. According to Stat News, two people have died, and six others were hospitalized after they received a stool transplant from OpenBiome. The patients who got sick received their stool transplants from three specific donors. The procedure of transplanting stool, called fecal microbiota transplant, or FMT for short, is not without risk. About one year ago, the FDA announced that the deaths of two people who had a stool transplant were connected to the FMT procedure directly.
The FDA and OpenBiome disagree whether both deaths referenced in the FDA’s Safety Alert were caused by stool transplants from donors at OpenBiome. The FDA indicates that one of the deaths could be linked to OpenBiome while the other is not. Meanwhile, OpenBiome adamantly denies that either death could be linked to its products or procedures.
The timing of the FDA’s Safety Alert comes at a precarious time for OpenBiome. A competitor to OpenBiome said that manufactured therapies that deliver microbe-based treatments could have greater efficacy and safety that FMT procedures.
OpenBiome is poised to forge ahead with safer samples. The company said that it would implement changes to its screening to identify and exclude samples that possibly contain deadly bacteria. OpenBiome will work to eliminate donors who have e. coli in their gut that produces a damaging Shiga toxin. A person with a Shiga toxin-producing e. Coli infection could exhibit symptoms such as cramping, diarrhea, blood-filled stools.
OpenBiome said that all of the infected patients have recovered. The company also says that one person who died had an underlying heart condition, and the other person who died did not test positive for Shiga toxin-producing e. Coli. Notwithstanding, the company admits that people did get sick from its products.
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