December 12, 2014 — The FDA has issued a Safety Warning about the risk of bacterial or fungal infections associated with probiotic supplements that contain live bacteria or yeast.
The warning was issued about a month after ABC Dophilus was recalled. A premature infant died after being given the supplement in a hospital in Connecticut.
The infant developed mucormycosis, a gastrointestinal fungal infection, caused by the mold Rhizopus oryzae. The mold was found in an unopened container of ABC Dophilus powder, which is formulated to contain three species of live bacteria.
The FDA is warning that dietary supplements, including those that contain live bacteria or yeast, are generally not regulated as drugs. The FDA warns:
“These products are not subject to FDA’s premarket review or approval requirements for safety and effectiveness, nor to the agency’s rigorous manufacturing and testing standards for drugs, including testing for extraneous organisms.”
Makers of dietary supplements are not allowed to market their products for the treatment of a disease. However, some studies recommend products like ABC Dophilus for the prevention of necrotizing enterocolitis in premature infant.
When the FDA reviewed clinical trial data, they found inadequate documentation of the safety risks associated with this treatment. Therefore, they advise doctors to use caution when using supplements in immunocompromised patients. They are also encouraging doctors to submit an Investigational New Drug Application (IND) for FDA review.
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