Drugs

Probiotics Can Hurt Hospitalized Preterm Infants: FDA

FDA is advising healthcare providers and the public about the possible risks that probiotic products containing live bacteria or yeast pose to hospitalized preterm infants. An agency news release (contains links to related materials) says the agency is concerned that such products are being illegally sold to treat or prevent diseases in preterm infants in hospital settings, such as to reduce the risk of necrotizing enterocolitis. “Preterm infants who are administered a probiotic product are at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast contained in the probiotics,” the release says.

According to the agency, using probiotics in hospitals to prevent necrotizing enterocolitis resulted in an infant death in 2023 and has been associated with more than two dozen other reported adverse events in the U.S. since 2018. FDA says it is investigating reports that the products may have contributed to additional adverse events, including death.

The agency says it has issued Warning Letters to Abbott Laboratories for its Similac Probiotic Tri-Blend and Infinant Health for its Evivo with MCT Oil. The release says Abbott has agreed to discontinue sales of its product and is working with FDA on other corrective actions, while Infinant has recalled its product.

“FDA understands there are conflicting data in the literature on the safety and effectiveness of probiotics for the prevention of necrotizing enterocolitis, and that the study of the use of probiotics has been complicated by several factors, including the use of different probiotics in different trials,” the release says. “Because of the potential for harm posed by these products in highly vulnerable individuals, such as preterm infants, the agency urges the industry, clinical, and research funding communities to focus on high-quality clinical trials with products meeting quality criteria to provide definitive evidence to inform the use of these products by healthcare providers and, where appropriate, to support applications for drugs and biological products for use in infants of any age.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome