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After Infant Death, FDA Issues Warning about Probiotic Dietary Supplements

Dec 22, 2014

The Food and Drug Administration (FDA) has issued a warning to health care providers about using dietary supplements containing live bacteria or yeast in patients with compromised immune systems.

Dietary supplements are not regulated in the United States as approved drugs, the FDA explains. “[T]hese 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.” But, according to the FDA, health care professionals use some dietary supplements in the manner of a drug, “to treat, mitigate, cure, or prevent a disease or condition.”

The warning follows the October 11th death of a premature infant from mucormycosis, an invasive fungal disease of the gastrointestinal tract, after receiving a probiotic supplement in a hospital neonatal intensive care unit, Forbes reports. The Centers for Disease Control and Prevention (CDC) identified the fungus Rhizopus oryzae in unopened bottles of ABC Dophilus, made by Solgar Inc. The dietary supplement, marketed for use in infants and children, contains three viable bacteria strains that the company claims “support good health in these populations by helping to maintain a healthy balance within the intestine’s microbial ecology.”

Solgar announced a voluntary recall of three lots of ABC Dophilus, which were distributed in 30 states, the UK, and Israel. The FDA, the CDC, and the Connecticut Department of Health are all investigating the infant’s treatment after the child, born at 29 weeks gestation, developed necrotizing enterocolitis (NEC). NEC can occur in premature infants whose organs have not finished developing. Underdeveloped intestines may not be able to exclude bacteria and a lethal infection can result, according to Forbes.

The Cochrane Collaboration, which conducts primary research in health care and health policy, reviewed 24 clinical studies on probiotic supplements and concluded that, “Enteral supplementation of probiotics prevents severe NEC and all cause mortality in preterm infants.” The FDA said this review is likely the rationale Connecticut health professionals used in justifying inpatient use of a dietary supplement. But a review by the U.S. Agency for Healthcare Research and Quality (AHRQ) cited the incomplete nature of safety assessment of these supplements. Forbes notes that probiotic supplements vary considerably in their composition and delivery method. Forbes reports that the fungal contamination of unopened bottles of ABC Dophilus implies an issue with manufacturing conditions.

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