Regulatory Oversight and Safety of Probiotic Use

Details

• Alternative Title:
  Emerg Infect Dis
• Personal Author:
  Venugopalan, Veena ; Shriner, Kimberly A. ; Wong-Beringer, Annie
• 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

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• Source:
  Emerg Infect Dis. 16(11):1661-1665.
• Document Type:
  Journal Article
• Name as Subject:
  United States. Food and Drug Administration. ; United States. Food and Drug Administration.
• Place as Subject:
  United States
• Location:
  North America
• Volume:
  16
• Issue:
  11
• 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:
  [PDF - 161.15 KB ]