Regulatory Oversight and Safety of Probiotic Use - EID Journal Home > Volume 16, Number 11–November 2010

EID Journal Home > Volume 16, Number 11–November 2010
Volume 16, Number 11–November 2010
Synopsis
Regulatory Oversight and Safety of Probiotic Use

Veena Venugopalan, Kimberly A. Shriner, and Annie Wong-Beringer Comments to Author
Author affiliations: University of Southern California, Los Angeles, California, USA (V. Venugopalan, A. Wong-Beringer); and Huntington Hospital, Pasadena, California, USA (K.A. Shriner, A. Wong-Beringer)

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Suggested citation for this article

Abstract
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.

Probiotics are defined by the Food and Agriculture Organization of the World Health Organization as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host (1). The term probiotic can be subcategorized to include probiotic drugs, probiotic foods (e.g., foods, food ingredients, and dietary supplements), direct-fed microbials (probiotics for animal use), and designer probiotics (genetically modified probiotics) (2). In the United States, probiotic products are marketed to a generally healthy population as foods or dietary supplements (3).

Recent increases in the incidence and severity of Clostridium difficile infection (CDI) have led some clinicians to consider use of probiotics as "drugs," either alone or in combination with traditional antimicrobial agents for the prevention and treatment of CDI. Several recent reviews have summarized results from clinical studies evaluating the efficacy of probiotics in diarrheal illness (4–12). Our goal is to highlight the current regulatory oversight for probiotics in the United States, identify potential risk situations associated with their administration, and offer suggestions on practical aspects of probiotic administration to ensure patient safety. This review focuses on Saccharomyces boulardii (Florastor; Biocodex Pharmaceutical Laboratories, Gentilly, France) as an example of a probiotic product being used as a "drug" to prevent or treat recurrent CDI, particularly in critically ill patients.

Suggested Citation for this Article

Venugopalan V, Shriner KA, Wong-Beringer A. Regulatory oversight and safety of probiotic use. Emerg Infect Dis [serial on the Internet]. 2010 Nov [date cited].
http://www.cdc.gov/EID/content/16/11/1661.htm

DOI: 10.3201/eid1611.100574

FULL-TEXT:
Regulatory Oversight and Safety of Probiotic Use | CDC EID