Pharmacy Services

Probiotic Supplements and Risk of Invasive Fungal Disease in Immunocompromised Persons

December 23, 2014

A premature infant died after developing gastrointestinal mucormycosis following the administration of the dietary supplement, ABC Dophilus Powder (manufactured by Solgar). This supplement, found to be contaminated with Rhizopus oryzae, was being used for the prevention of necrotizing enterocolitis. ABC Dophilus Powder is intended to contain Bifidobacterium lactis, Streptococcus thermophilus, and Lactobacillus rhamnosus. FDA and CDC continue to investigate the death of the preterm infant.  Solgar issued a recall for three lots of ABC Dophilus Powder in mid-November and advises consumers to avoid using the recalled product.  CDC recommends avoiding use of all Solgar ABC Dophilus Powder. Return ABC Dophilus Powder to the place of purchase for a full refund.

Some literature supports the use of dietary supplements, such as ABC Dophilus Power, for this indication in preterm infants. However, FDA cautions that there is inadequate information regarding the safety of these products. Dietary supplements are not subject to the same rigorous standards as drugs.  FDA recommends that healthcare providers submit an Investigational New Drug Application (IND) when using dietary supplements that contain live bacteria or yeast.

Symptoms of mucormycosis depend on the site of infection. Gastrointestinal mucormycosis primarily occurs in immunocompromised individuals (eg, preterm infants). Symptoms of gastrointestinal mucormycosis include nausea, vomiting, fever, and abdominal pain. Patients with these symptoms who have ingested ABC Dophilus within the past 30 days should seek medical attention. Report adverse events to FDA’s MedWatch Adverse Event Reporting program online:  http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm

Additional information is available at the following links:

Updated December 23, 2014; University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.