The FDA is warning those who are immunocompromised against taking dietary supplements that contain live bacteria or yeast and is warning healthcare providers about the use of these products in susceptible patients. A premature infant who was given ABC Dophilus Powder as part of an in-hospital treatment developed gastrointestinal mucormycosis caused by the mold Rhizopus oryzae and died. Rhizopus oryzae mold was found in an unopened container of the ABC Dophilus Powder. The FDA has sent a letter to healthcare providers around the country regarding this issue.
That product was recalled on November 14, 2014 by the FDA for the mold. After the infant’s death, FDA is telling healthcare providers that dietary supplements are not regulated as drugs by the FDA. They 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.”
Gastrointestinal mucormycosis occurs mostly in immunocompromised persons, such as premature infants. FDA advises practitioners to approach the use of these interventions with caution. And FDA encourages all health care providers who use dietary supplements containing live bacteria or yeast as drugs to submit an Investigational New Drug Application for FDA review.
Some healthcare providers do use dietary supplements to treat, mitigate, cure, or prevent a disease or condition. Those providers and consumers should know about the risks of taking these products, especially if they have an underlying health condition or are immune compromised. And as always, health care providers and consumers are encouraged to report adverse events following the use of dietary supplements to the manufacturer and to the FDA at the Safety Reporting Portal.
