FDA Issues Warning for Probiotic Supplements
About the Proboitic Warning
The warning discourages the use of dietary supplements containing live bacteria in patient with compromised immune systems.
According to a release from the FDA, the products do not require FDA approval prior to being released on the market and do not undergo the safety and efficacy tests that pharmaceuticals must undergo.
The FDA also noted concern that a hospital would be using non-FDA approved products for inpatient treatment. While the FDA acknowledges that there is no law restricting the use of such products, the agency does urge hospitals to only use supplements that are accompanied by an Investigational New Drug Application.
FDA Investigates Infant Death
- The decision follows the death of a pre-term infant in October. The child, who received a propbiotic supplement while in a neonatal care unit, died from an invasive fungal disease called mucormycosis.
- The FDA, U.S. Centers for Disease Control and Prevention (CDC), and Connecticut Department of Health have all launched investigations into the death of the infant.
- The child was born at 29 weeks gestation and was being treated for necrotizing enterocolitis (NEC), a condition that can occur in premature infants with under-developed organs.
- The discovery of a fungal contamination in an unopened bottle of ABC Dophilus, the supplement used to treat the infant, suggests a manufacturing issue. The product has sense been recalled.