USA – Mucormycosis, fatal, premature infant, probiotic, recall, alert
November 17, 2014 | ISID [edited]
CDC, FDA, and the Connecticut Department of Public Health are investigating a fatal case of GI [gastrointestinal] mucormycosis in a premature infant of 29 weeks gestation following the use of a probiotic supplement called ABC Dophilus distributed by Solgar, Inc., Leonia, NJ.
Shortly after birth, the infant received a probiotic supplement called ABC Dophilus, distributed by Solgar Inc., as prophylaxis against necrotizing enterocolitis (NEC). Subsequently, the infant developed signs and symptoms consistent with NEC. Surgical exploration revealed necrotic bowel, which was resected. Histopathology results from the resected bowel revealed a heavy fungal burden with angioinvasion, consistent with a Mucormycete infection.
Sequencing of fungal DNA recovered from the infant’s tissue block identified the fungus as _Rhizopus oryzae_, a pathogenic Mucormycete. _R. oryzae_ was also recovered from unopened bottles of Solgar ABC Dophilus, lot no. 074 024 01R1, the same lot administered to the infant. Solgar ABC Dophilus is a probiotic product intended to contain _Bifidobacterium lactis_ and _Lactobacillus rhamnosus_ and has been used to prevent NEC in premature infants. This product is available for purchase in retail stores and online retailers and is used in healthcare settings.
The investigation into this fatal case of GI mucormycosis and its association with the contaminated Solgar ABC Dophilus is ongoing. As such, Solgar ABC Dophilus should not be used, especially in infants and children who may be more susceptible to infection, until further information regarding the safety of this product is available.
Clinicians who learn of:
1. Confirmed or suspected cases of infants with gastrointestinal mucormycosis (diagnosed via culture or histopathology), OR
2. Unexplained infant deaths within 30 days of receipt of Solgar ABC Dophilus since 1 Nov 2013 are asked to notify CDC Mycotic Diseases Branch, Dr. Tiffany Walker at <firstname.lastname@example.org> or 404-639-2641.