Other safety alerts
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| The United States: Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning - Risk of Invasive Fungal Disease |
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The US Food and Drug Administration (FDA) is warning health professionals of the risks associated with the regarding use of dietary supplements containing live bacteria or yeast in immunocompromised persons.
A premature infant administered a dietary supplement, ABC Dophilus Powder (Solgar), as part of in-hospital course of treatment, developed gastrointestinal mucormycosis caused by the mold Rhizopus oryzae and died. Rhizopus oryzae mold was found to be present as a contaminant in an unopened container of the ABC Dophilus Powder, which is formulated to contain three species of live bacteria.
FDA, along with the Centers for Disease Control and Prevention (CDC) and the Connecticut Department of Public Health, are investigating the death of this preterm infant who developed gastrointestinal mucormycosis. In mid-November, Solgar issued a recall for certain lots of ABC Dophilus Powder and public health warnings were issued advising customers and consumers not to use the recalled product.
FDA is informing healthcare providers that dietary supplements, including those that are formulated to contain live bacteria or yeast, are generally not regulated as drugs by the FDA. As such, these products are not subject to FDA’s premarket review or approval requirements for safety and effectiveness, nor to the agency’s rigorous manufacturing and testing standards for drugs, including testing for extraneous organisms.
FDA is warning health professionals of the potential risks associated with the use of dietary supplements containing live bacteria or yeast in immunocompromised persons. Gastrointestinal mucormycosis primarily occurs in immunocompromised persons, such as prematurely born infants.
FDA is aware of recommendations in the peer reviewed literature regarding the use of live bacteria in the prevention of necrotizing enterocolitis in premature infants. However, FDA cautions that a systematic review of the clinical trial literature found inadequate documentation of the safety of the interventions, and advises practitioners to approach the application of these interventions with caution.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm426331.htm
In Hong Kong, ABC Dophilus Powder (Solgar) is not a registered pharmaceutical product. News regarding ABC Dophilus Powder (Solgar) may pose a serious health risk had been released by FDA and TGA, and was posted on the Drug Office website on 18 November and 29 November 2014.
Ends/ Wednesday, December 10, 2014
Issued at HKT 13:00
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