FDA Issues Warning Against Giving Probiotics to Preterm Infants Following Death and Injuries

FDA not only warns of potential probiotics risks for hospitalized preterm, but takes actions against illegal marketing by Abbott Laboratories and Infinant Health, amidst reports of over two dozen injuries and death since 2018.

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.