Federal health officials are warning doctors that the use of some in-hospital dietary supplements could increase the risk of invasive fungal disease among certain patients.
The FDA issued a fungal disease warning (PDF) for healthcare professionals on December 9, indicating that dietary supplements that contain live bacteria or yeast may endanger the health of individuals with compromised immune systems.
The primary focus of the warning was ABC Dophilus Powder distributed by Solgar, Inc., a probiotic believed by some to help prevent necrotizing enterocolitis (NEC). However, the agency extended the warning to all dietary supplements with live bacteria.
The warning comes following the October death of an infant who was given ABC Dophilus Powder and then developed a fatal case of gastrointestinal mucormycosis, which investigators say was caused by Rhizopus oryzae, a mold contaminant later found in the powder.
On November 17, Solgar issued an ABC Dophilus Powder recall due to the risk of bacterial contamination. That was followed by a warning by the U.S. Centers for Disease Control and Prevention that the incident was under investigation.
The FDA warning this week notes that the mold was present in unopened containers of the powder. However, the warning is more broad than just the recalled Solgar product, according to the agency.
“In light of the case of fatal gastrointestinal mucormycosis described above, FDA is informing healthcare providers that dietary supplements, including those that are formulated to contain live bacteria or years, are generally not regulated as drugs by the FDA,” the warning notes. “As such, 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.”
The agency said it was aware of some peer-reviewed studies that found the use of live bacteria could stave off NEC in infants. referring to a review published in April by The Cochrane Library.
“However, FDA cautions that a systemic review of the clinical trial literature found inadequate documentation of the safety of the interventions, and advises practitioners to approach application of these interventions with caution.”