The U.S. Federal Drug Administration (FDA) recently released a warning stating that ‘repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains’ (www.fda.gov/ucm582356.htm). The goal of this article is to review the most recent clinical studies which provide evidence that these concerns may be overstated for the majority of healthy young children who require surgery and anesthesia.


Three large retrospective matched cohort studies published within the past year provide data on a total of 59 814 children exposed to general anesthesia before age 4 (including 30 021 <2 years and 9814 multiple exposure). All three studies independently conclude that neither exposure to anesthesia in children under 2 years of age nor multiple exposures are associated with adverse neurodevelopmental consequences in the patient populations studied. Biological, environmental, and social factors were found to be of far greater import.


These findings suggest that anesthetic neurotoxicity is not a major contributory pathway for adverse neurodevelopmental outcomes in the majority of healthy children who require surgery before 3 years of age. Future work should focus on the particular vulnerabilities of the fetus, premature infant, and children with developmental disabilities, major congenital, cardiac or neurological abnormalities not specifically addressed by these studies.