Repeated use of general anesthetic and sedation drugs — or use for longer than 3 hours — in children under age 3 years and in pregnant women in their third trimester could adversely affect child brain development, the FDA warned on Wednesday.
The agency cited animal data showing that early, lengthy exposure to these drugs caused neuronal and oligodendrocyte cell loss in the brain, which was associated with long-term effects on learning and memory. Meanwhile, some studies in humans have shown associations between early anesthesia exposure and later cognitive and behavior problems, while others have not.
The FDA notes that “a single, relatively short exposure to general anesthetic and sedation drugs … is unlikely to have negative effects on behavior or learning.”
The agency advises clinicians to weigh the benefits and potential risks of anesthesia in young children and pregnant women, “especially for procedures that may last longer than 3 hours or if multiple procedures are required in children under 3 years.”
The drugs’ labels will be updated to note these potential risks. A list of the affected drugs is available in the FDA safety communication linked below.