This week, the CDC published an article about a tragic case of gastrointestinal mucormycosis in a preterm baby linked to ABC Dophilus® Powder, an over-the-counter dietary supplement containing live bacteria, including Bifidobacterium lactis BB-12 (BB-12®) and Lactobacillus rhamnosus GG (LGG®). This product is manufactured by Solgar, Inc., a New Jersey company.
In October 2014, a hospital in Connecticut notified CDC of a fatal case of gastrointestinal mucormycosis in a preterm infant. This condition, which causes intestinal tissue to die, is caused by infection with a specific type of fungi (mold in the order Mucorales), and it has an 85% mortality rate.
Before we continue a discussion of the case, we want to express or deepest sympathy to the family of this little one. As will be discussed below, this death was most likely caused by a product contaminated with deadly mold. The parents trusted the makers of ABC Dophilus to only sell a safe product. That did not happen here.
The infected infant, was born at 29 weeks’ gestation, weighing about 3 pounds at birth. About 1 week after birth, the baby developed signs and symptoms consistent with necrotizing enterocolitis (NEC), a condition much like gastrointestinal mucormycosis that also causes intestinal tissue to die off.
The infant soon developed complications not consistent with NEC, including a large clot in the aorta, and died.
Tests done on the baby’s cecum (part of the large intestine) revealed a fungal infection consistent with mucormycosis. The investigation into this death revealed that the baby had been given a dietary supplement, ABC Dophilus Powder, for 7 days, beginning on day 1 of life. The hospital fed the baby this product to prevent NEC.
The hospital microbiology lab found mold capable of causing mucormycosis in cultures of product from unopened bottles of ABC Dophilus Powder from the lot received by the infant. The CDC later confirmed that the mold was a fungus called Rhizopus oryzaewere. This was the exact same fungus found in tissue samples of the infant’s cecum that had caused the fungal infection.
On November 14, 2014, Solgar Inc., issued a recall of several product lots, including the one fed to the infant.
Dietary Supplements Not Regulated as Drugs
Dietary supplements, such as ABC Dophilus Powder, are regulated by the FDA, but not as drugs, which means they are not subject to:
- FDA’s premarket review and approval requirements for safety and effectiveness
- The rigorous manufacturing and testing standards for drugs.
Dietary supplements are regulated by the FDA as foods, subject only to good manufacturing practice requirements.
Our lawyers are calling for a reclassification of dietary supplements used in a medical setting as drugs. This would require manufacturers to adhere to strict manufacturing and testing standards meant to prevent contamination with deadly pathogens, including fungi, viruses and bacteria like E. coli, Listeria, Salmonella and Staphylococcus.