I shiver.  I feel just another money-making opportunity to mess up the
perfect function of breast milk in the newborn/baby gut.  I found the
article below most immediately, and I'm sure there's more.  The only
probiotics an exclusively bf'd baby needs are in human milk, no?

Probiotics, like other food supplements and vitamins, are not regulated or
tested: Here's the article:

 

As I said, I shiver.

Jackie Levine

 

CDC Warns Against Use of Dietary Supplement After Infant Death

A premature infant in Connecticut has died of gastrointestinal mucormycosis
after ingesting a dietary supplement contaminated with the mold Rhizopus
oryzae, the Centers for Disease Control and Prevention (CDC) announced
yesterday in a Health Alert Network (HAN)
<http://www.cdc.gov/fungal/rhizopus-investigation.html> advisory.The infant
of 29 weeks' gestation received ABC Dophilus Powder from lot 074 024 01R1
for 4 days beginning on the first day of life as part of the in-hospital
care. ABC Dophilus Powder is a dietary supplement said to contain the
probiotic bacteriaBifidobacterium lactis, Streptococcus thermophilus,
andLactobacillus rhamnosus.

Following ingestion, the infant subsequently developed signs and symptoms
consistent with necrotizing enterocolitis (NEC). According to the CDC,
"Surgical exploration of the infant's GI tract revealed a necrotic bowel,
which was resected; histopathology results from the resected bowel revealed
a heavy fungal burden with an organism consistent with a mucormycete.
Immunohistochemical staining of the tissue block performed locally and at
CDC was positive when tested with a monoclonal antibody known to react with
several mucormycete fungal agents. Sequencing of fungal DNA from the tissue
identified the mucormycete as Rhizopus oryzae."Tests conducted by the CDC on
unopened samples from the implicated lot revealed contamination with
Rhizopus oryzae, a known cause of mucormycosis.

On November 14, Solgar Inc. issued a
<http://www.fda.gov/Safety/Recalls/ucm423219.htm> voluntary recall of three
lots of ABC Dophilus Powder: lot 74024-01R1, 074024-01, and 074024- 02, all
with an expiration date of July 31, 2015.The recalled product was
distributed to 29 US states, Puerto Rico, the United Kingdom, and Israel
through pharmacies, retail stores, wholesalers, and online retailers.

Recommendations for Clinicians"Healthcare facilities and providers should
stop using Solgar ABC Dophilus, especially among infants who may be more
susceptible to infection with mucormycosis, while this investigation is
ongoing," the CDC says.The agency advises clinicians evaluating preterm
infants for NEC or infants who have signs or symptoms of gastrointestinal
mucormycosis, such as abdominal pain, abdominal distension, nausea, or
vomiting, to determine whether Solgar ABC Dophilus Powder was used as part
of the infant's care.

If Solgar ABC Dophilus Powder was consumed by the patient within the
previous 30 days, clinicians should consider consultation with an infectious
disease physician to assist in an assessment, which may include aggressive
evaluation for a source of infection, including surgical exploration and
empiric treatment with antifungals active against mucormycete infections,
the CDC says.This dietary supplement is marketed specifically for infants
and children, the CDC notes in the HAN advisory. "This product and other
dietary supplements thought to have probiotic effects have been used in
preterm infants on the basis of a recent  <http://tinyurl.com/lqzv8ff>
Cochrane review supporting their use for prophylaxis against necrotizing
enterocolitis (NEC), a possible complication in preterm infants," the
advisory notes.

"ABC Dophilus Powder is intended for use as a dietary supplement and, as
such, is not regulated as a drug by the FDA. FDA has not evaluated the
safety of this product for any intended use and has not evaluated the
veracity of any claims of probiotic or other health benefits," the advisory
says.

The CDC, the US Food and Drug Administration (FDA), and the Connecticut
Departments of Public Health and Consumer Protection are investigating the
case, and national case finding efforts are under way.

The HAN advisory asks clinicians and public health officials to notify their
state or local health departments if they learn of confirmed or suspected
cases of infants with gastrointestinal mucormycosis (diagnosed via culture
or histopathology) or unexplained infant deaths within 30 days after
ingesting Solgar ABC Dophilus Powder occurring since November 1,
2013.Consumers who have purchased this dietary supplement should not use the
product and should return it to the place of purchase for a full refund, the
company says. Consumers with questions may contact the company at
1-888-534-6370, Monday through Friday, 9 AM to 7 PM Eastern Time.More
information about this HAN advisory is available on the CDC
<http://www.cdc.gov/fungal/rhizopus-investigation.html> website.

 


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