Overview

• The FDA has issued a warning against administering probiotics to preterm infants, following an infant's death and other injuries due to the use of these products.
• The warning was catalyzed by a preterm infant developing sepsis and later dying, after being given a probiotic in a hospital setting.
• Since 2018, probiotics' use in preterm infants has been linked to over two dozen reported adverse events.
• The FDA sent warning letters to Abbott Laboratories and Infinant Health, accused of illegally marketing their probiotic products for disease treatment or prevention in preterm infants.
• Probiotics, which contain live organisms such as bacteria or yeast, pose a risk of potentially fatal infections or disease in preterm infants.