Federal health officials are cautioning consumers about a probiotic dietary supplement for children that has caused the death of a premature Connecticut baby and may be dangerous to others.
The U.S. Food and Drug Administration has issued a warning about the product, ABC Dophilus Powder, manufactured by Solgar in Leonia, N.J. The company has voluntarily recalled the product, which contains live bacteria and yeasts.
Investigators with the Centers for Disease Control and Prevention are investigating the death because the baby developed gastrointestinal mucormycosis after ingesting the supplement, which was contaminated with the mold Rhizopus oryzae. The infant died in October.
The FDA said in a statement that the product had been formulated to contain three species of live bacteria.
The infant was given the product in a hospital, which has not been named by either the FDA or the CDC, during a course of treatment. Probiotic products are designed to provide “good†intestinal bacteria as a way to prevent disease, and boost health and immunity.
Before its recall, the product was available in health food stores and online. Consumers who still have the product are advised to dispose of it.
Dr. Kenneth Spaeth, division chief of occupational and environmental medicine at North Shore University Hospital in Manhasset, said dietary supplements do not have to meet rigorous safety standards.
Spaeth uncovered several Long Island illnesses last year linked to tainted vitamins manufactured in Farmingdale. He said tighter regulation of the industry is needed to protect consumers.
“It’s a problem,†Spaeth said. “Over the years, the more popular supplements become, the greater the number cases of people becoming ill.â€
He said it’s heart-wrenching that a premature baby died, but the lack of regulation means more people would be harmed by dietary aids.
“This is a wide-scale issue and despite that, there has been little done to try to tighten up the regulation and ensure safety and quality assurance. For this industry, it’s long overdue. We need better ways to protect the public,†Spaeth said.
In 2012, two other probiotic products aimed at children, iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder Dietary Supplements, were linked to salmonella contamination. Presence of the fungus forced the company to recall multiple lots.
After the Connecticut baby was given the probiotic, intestinal damage known as necrotizing enterocolitis occurred, according to the CDC. In that disorder, intestinal tissue dies. Tissue samples revealed a significant amount of fungal invasion in the infant’s intestinal tract.
Dr. Mindy Haar, director of program development and interdisciplinary health sciences at New York Institute of Technology in Old Westbury, said studies suggest that probiotic supplementation may beneficially aid premature infants.
However, she bemoaned that the product chosen by Connecticut doctors could not have been tested for safety.
“Probiotics can act as a barrier to harmful bacteria in the gastrointestinal tract,†she said. “But in this case, it was tragic.â€
She said she tells her students that dietary supplements are innocent until proven guilty, but guilt occasionally can mean sickness or death for consumers.
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