Tragic result of unregulated product

Gary A. Emmett, M.D., director of hospital pediatrics at Thomas Jefferson University Hospital, wrote this for Philly.com's "Healthy Kids" blog.

The Centers for Disease Control and Prevention recently put out a health advisory after a premature infant in Connecticut died in October of a rare fungal infection of the intestines called mucormycosis.

The baby first had signs and symptoms of necrotizing enterocolitis (NEC), which results from poor blood flow to the gut. NEC is a major cause of disability and death in sick premature babies and is diagnosed after the sudden development of fever, swollen abdomen, and inability to feed.

However, in October, the entire gut from stomach to anus was involved, instead of a localized segment of the bowel, which led to further testing. The hospital laboratory cultured a mold, Rhizopus oryzae, from the child's blood that seemed to be responsible, but where did it come from?

Human beings have 10 times as many bacteria in their gastrointestinal tract as they have human cells in their whole bodies. Newborns get most of these necessary bacteria that help their bodies work from their mothers, but in an ill newborn, this normal transference of gut flora is interrupted by arriving early and being isolated from the mother in the sick-baby nursery and, often, by antibiotics, which kill off the needed bacteria along with the dangerous ones.

A recent review combining many studies has recommended that probiotics be given to premature babies to replace the gut bacteria that they lack. NEC seems to result from a lack of proper gut-flora transport from mother to child, so probiotic dietary supplementation was given. In this case, the hospital used ABC Dophilus Powder by Solgar Inc. of Leonia, N.J.

Since probiotics are classified as "dietary supplements," they are not regulated as drugs by the U.S. Food and Drug Administration. When unopened bottles of this supplement were cultured, they grew the same rare mold that apparently killed this premature baby.

On Nov. 14, Solgar issued a voluntary recall of a few ABC Dophilus Powder lots. A spokeswoman said last week that the company was cooperating fully. She called this an isolated incident and said 1,800 bottles were involved. This product was distributed to 29 states, including Pennsylvania and New Jersey.

Disruption of the microscopic biological flora of the gut is a major cause of illness and is probably a contributor to such widely disparate problems as inflammatory bowel disease, chronic abdominal pain, and obesity.

Live-culture yogurt and over-the-counter probiotics are strongly recommended by many medical practitioners, including myself, but this contamination in a product intended for newborns is disturbing. Regulation for purity and of cleanliness of dietary supplements must be seriously considered in the United States, as it already is in Germany and other European nations.

The CDC recommends:

Solgar ABC Dophilus Powder should not be used, especially in infants, who may be especially susceptible to infection.

In considering the use of supplements, clinicians should know that the FDA does not regulate these products as drugs.

Concerned about this case? Contact your representatives and tell them supplements for children should follow FDA rules on cleanliness and purity. Know that "all natural" does not mean "good for you" - or even safe.