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Fitzgerald Health Education Associates, Inc., December 2014 fhea.com
News Briefs
Dietary Supplements with Live Bacteria
or Yeast Dangerous in
Immunocompromised Patients
The FDA is warning health professionals about the
risks associated with the use of dietary supplements
containing live bacteria or yeast in immunocompro-
mised individuals. The agency reports that a prema-
ture infant who was administered a dietary
supplement, ABC Dophilus Powder (Solgar, Leonia,
NJ), as part of an in-hospital course of treatment de-
veloped gastrointestinal mucormycosis caused by
the mold Rhizopus oryzae and died. The mold was
found present as a contaminant in an unopened
container of ABC Dophilus Powder, which is formu-
lated to contain three species of live bacteria.
The death of this infant prompted the FDA and
the US Centers for Disease Control and Prevention
and the Connecticut Department of Public Health to
investigate the case. Sol-
gar issued a recall of
certain lots of ABC
Dophilus Powder and
public health warn-
ings were issued
about the recalled
product.
The FDA is warning that
dietary supplements, includ-
ing those formulated to contain live
bacteria or yeast, are usually not regulated as drugs
by the agency and thus are not subjected to the
FDA's premarket review or approval requirements for
safety and effectiveness. Nor are they subject to the
FDA's manufacturing and testing standards for
drugs, including testing for extraneous organisms.
Click here for more information.
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