Federal regulators have sent warning letters to two companies for illegally selling probiotic products for use in preterm infants. The U.S. Food and Drug Administration also sent a letter to health care providers warning of the risks. Probiotic products contain live organisms...
Federal regulators have sent warning letters to two companies for illegally selling probiotic products for use in preterm infants.
These products may be dangerous for preterm infants and are being illegally sold to treat or prevent diseases in preemies in hospitals, such as necrotizing enterocolitis. “Adverse events in any infant following the use of a probiotic are a concern to the FDA. We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency news release.
A warning letter was sent to Abbott Laboratories on Oct. 24 for its Similac Probiotic Tri-Blend, which contains B. infantis , S. thermophilus and B. lactis .This situation is not related to other issues with powdered infant formula made by Abbott, the FDA noted. “We are encouraging all involved in the care of preterm infants — including parents, caregivers and health care providers — to be aware of the possible risks associated with the administration of probiotic products to preterm infants in hospital settings," Jones added.
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FDA warns against giving probiotics to babies after infant deathBerkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.
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FDA warns about giving probiotics to babies after infant deathBerkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.
Read more »
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FDA warns about giving probiotics to preterm babies after infant death, other injuriesFederal officials are warning health care providers and the public about injuries and at least one death in premature infants who were given probiotic products in the hospital.
Read more »
FDA warns about giving probiotics to preterm babies after infant death, other injuriesFederal officials are warning health care providers and the public about injuries and at least one death in premature infants who were given probiotic products in the hospital.
Read more »