CDC Health Advisory: Fatal Gastrointestinal Mucormycosis in an Infant Following Ingestion of Contaminated Dietary Supplement – Connecticut, 2014
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CDC Health Advisory: Fatal Gastrointestinal Mucormycosis in an Infant Following Ingestion of Contaminated Dietary Supplement – Connecticut, 2014

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      November 25, 13:45 EST (1:45 PM EST)


      Summary: The Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Connecticut Departments of Public Health and Consumer Protection are investigating a fatal case of gastrointestinal (GI) mucormycosis caused by Rhizopus oryzae in a premature infant. The infant received ABC Dophilus® Powder, a dietary supplement product containing viable microbial ingredients purchased from Solgar, Inc., Leonia, New Jersey. The product claimed to have “probiotic” properties and is marketed for infants and children. Subsequent testing of the same lot of unopened Solgar ABC Dophilus® Powder revealed contamination with Rhizopus oryzae. The purpose of this HAN advisory is to provide awareness about this fatal case of GI mucormycosis following ingestion of a contaminated dietary supplement and to provide guidance to state health departments and health care providers. Please disseminate this information to healthcare workers in neonatal intensive care units, hospital pharmacies, pediatricians, and primary care providers, as well as to microbiology and pathology laboratories.

      Background: Mucormycosis is a rare infection caused by mold in the order Mucorales, including Rhizopus spp. GI mucormycosis is a very rare manifestation of this disease and occurs when mucormycosis involves the GI tract causing signs and symptoms such as:

      • abdominal pain

      • abdominal distension

      • nausea

      • vomiting

      These symptoms are thought to occur primarily when a susceptible person ingests the fungus, and they usually occur in immunocompromised individuals.

      In October 2014, a hospital in Connecticut notified CDC and the Connecticut Department of Public Health of a fatal case of gastrointestinal mucormycosis in a preterm infant of 29 weeks’ gestation. The infant received lot 074 024 01R1 of ABC Dophilus® Powder for four days, beginning on day one of life. ABC Dophilus® Powder is a product intended to contain three bacteria, Bifidobacterium lactis, Streptococcus thermophilus, and Lactobacillus rhamnosus. The product was purchased from Solgar, Inc., Leonia, NJ, and is marketed specifically for infants and children. This product and other dietary supplements thought to have probiotic effects have been used in preterm infants on the basis of a recent Cochrane review supporting their use for prophylaxis against necrotizing enterocolitis (NEC), a possible complication in preterm infants. ABC Dophilus ® Powder is intended for use as a dietary supplement and, as such, is not regulated as a drug by the FDA. FDA has not evaluated the safety of this product for any intended use and has not evaluated the veracity of any claims of probiotic or other health benefits.

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