Details:

Alternative Title:
Emerg Infect Dis
Personal Author:
Venugopalan, Veena ; Shriner, Kimberly A. ; Wong-Beringer, Annie
Venugopalan, Veena ; Shriner, Kimberly A. ; Wong-Beringer, Annie Less -
Description:
Depending on intended use of a probiotic (drug vs. dietary supplement), regulatory requirements differ greatly. For dietary supplements, premarketing demonstration of safety and efficacy and approval by the Food and Drug Administration are not required; only premarket notification is required. Saccharomyces boulardii is a probiotic regulated as a dietary supplement intended for use by the general healthy population, not as a drug to prevent, treat, or mitigate disease. However, since recent increases in incidence and severity of Clostridium difficile infection, probiotics have been used to treat recurrent and/or refractory disease in hospitalized patients. Saccharomyces fungemia secondary to use of the probiotic has been described for patients who are critically ill, are receiving nutrition enterally, or have a central venous catheter. Before use of a probiotic is considered for hospitalized patients, careful assessment of risk versus benefit must be made. To ensure patient safety, probiotics should be properly handled during administration.
Subjects:
[+]
Contraindications Critical Illness Dietary Supplements Enterocolitis, Pseudomembranous/prevention & Control Fungemia/microbiology Humans Legislation, Drug Probiotics Saccharomyces Secondary Prevention Synopsis
Source:
Emerg Infect Dis. 16(11):1661-1665.
Document Type:
Journal Article
Name as Subject:
United States. Food and Drug Administration.
Place as Subject:
United States
Collection(s):
Emerging Infectious Diseases
Main Document Checksum:
[+]
urn:sha256:ab6021fb4a0449d12e8aeab6da224a0343b87f8cc75aa295db4c8426dcf49dda
Download URL:
https://stacks.cdc.gov/view/cdc/18326/cdc_18326_DS1.pdf
File Type:

Supporting Files

• 	10-0574_finalS.nxml	txt
  	license.txt	txt

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