December 12, 2014 — The FDA is warning doctors to think twice before using probiotic supplements to treat diseases in immunocompromised patients.
One month ago, a premature infant died after it was given ABC Dophilus, which is a powder that is formulated to contain three species of live bacteria.
The infant developed a gastrointestinal fungal infection known as mucormycosis. The infection was caused by the mold Rhizopus oryzae, which was also discovered in an unopened container of ABC Dophilus.
The manufacturer, Solgar Inc., issued a recall on November 17.
The FDA cautions that supplements are not generally regulated as drugs, even if they contain live bacteria or yeast:
“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.”
Several peer-reviewed studies have recommended probiotics to prevent necrotizing enterocolitis in premature infants. An FDA review of the medical literature found these studies lacked adequate documentation of the safety risks.
The FDA asks doctors to use caution when administering supplements in immunocompromised patients. They have also asked doctors to submit an Investigational New Drug Application (IND) when they use probiotics to treat or prevent diseases.
Do I have an ABC Dophilus Lawsuit?
The Schmidt Firm, PLLC is currently accepting ABC Dophilus induced injury cases in all 50 states. If you or somebody you know has been diagnosed with mucormycosis or another infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dietary Supplement Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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