The US Food and Drug Administration is sharing a new warning about the risks of probiotics for hospitalized preterm infants. The products have been linked with over two dozen reported adverse events since 2018 and one death in 2023, the agency said.
On Thursday, the agency announced it had sent a warning letter to Abbott Laboratories for its Similac Probiotic Tri-Blend product, which the FDA described as an unapproved new drug and unlicensed biological product based on statements on its website and in marketing materials. The company agreed to discontinue sales of the product, the agency said.
In a warning letter, the agency cautioned health care providers that bacteria and fungi found in probiotics might put preterm infants at risk of “invasive, potentially fatal” infections. The product was recalled after the FDA sent the warning letter and is no longer available in the US. The FDA emphasized that it hasn’t approved any probiotic products for infants of any age, and products haven’t been evaluated for safety, effectiveness or compliance with manufacturing and testing standards.
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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 »
FDA warns against giving probiotics to preterm babies after infant's deathU.S. Food and Drug Administration is advising against using probiotic products for preterm infants due to potentially fatal health risks.
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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. The FDA says that one death this year and more than two dozen reports of other injuries since 2018 may be tied to the supplements.
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