The CDC, FDA, and Connecticut Departments of Public Health and Consumer Protection, are investigating a fatal case of gastrointestinal mucormycosis in a premature infant, born at 29 weeks gestation. The death has been linked to the use of a dietary supplement (probiotic) called ABC Dophilus, distributed by Solgar, Inc., a New Jersey company.
After birth, the infant was given ABC Dophilus to help prevent necrotizing enterocolitis (NEC), a severe illness that causes inflammation in the intestines (generally the colon). It can eat a hole through the intestine, allowing the infection to spread into the abdomine.
Not long after the use of ABC Dophilus, the infant developed signs and symptoms of NEC, according to the CDC. Symptoms can include:
- swelling of the tummy;
- abnormal redness of the tummy;
- obvious problems at feedings;
- vomiting (may be green);
- bloody stools;
- fever; and
- apnea or other breathing issues.
When surgery was done, doctors found a necrotic bowel (dead tissue). Tests found that the child had a fungal infection, specifically gastrointestinal (GI) mucormycosis. DNA sequencing identified the fungus as Rhizopus oryzae, one in a group of fungi called Mucoromycotina. Human fungal infections from Rhizopus oryzae are rare.
Tests on unopened bottles of ABC Dophilus found Rhizopus oryzae. The bottles were the same lot administered to the infant.
This case reminds us again that dietary supplements, , including those formulated for infants, are not regulated as drugs by the FDA. 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. This is true even where the supplements are used for vulnerable premature infants. The FDA must work to close this dangerous loophole.
Solgar ABC Dophilus is a probiotic dietary product intended to contain Bifidobacterium lactis and Lactobacillus rhamnosus. It is available for purchase in retail stores, online (to the general public) and in healthcare settings, where it has been used to prevent NEC in premature infants.
The investigation into this fatal case of GI mucormycosis and its association with the contaminated Solgar ABC Dophilus prompted both a recall of ABC Dophilus and an FDA Safety Alert warning doctors and hospitals about the use of probiotic dietary supplements.
Urgent: Your baby may have been sickened or killed by ABC Dophilus if:
1. Your preterm baby had a confirmed or suspected case of gastrointestinal mucormycosis; or
2. Your preterm baby died within 30 days of the use of Solgar ABC Dophilus.
Solgar ABC Dophilus Recall
Product Recalled: Solgar ABC Dophilus® Powder NET Wt. 1.75 oz (50 g)
UPC Code: 0 33984 00010 0
Lot Numbers: Lot# 074024-01R1, 074024-01, 074024-02
Expiration Date: 7/31/15
The product was distributed to: Alabama AL, Arkansas AR, Arizona AZ, California CA, Connecticut CT, Colorado CO, Florida FL, Iowa IA, Illinois IL, Indiana IN, Michigan MI, Maine ME, Montana MO, Massachusetts MA, North Carolina NC, Nebraska NE, New York NY, New Jersey NJ, Nevada NV, Ohio OH, Oklahoma OK, Pennsylvania PA, Puerto Rico PR, Utah UT, Tennessee TN, Texas TX, Vermont VT, Kentucky KY, Wisconsin WI, Washington WA, UK and Israel.