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In December of 2016, the US Food and Drug Administration (FDA) released a safety warning concerning the risk of repeated use of general anesthetics and sedation drugs in young children and pregnant women1.  From a review of the literature, including both animal and human studies, the FDA found consensus data to suggest that early, repeated exposure may have negative effects on the developing brain.  Particularly vulnerable to such effects are fetuses of women in their third trimester of pregnancy and children younger than 3 years of age.

Interestingly, this announcement comes on the heels of two recently published retrospective clinical trials (“General Anaesthesia and Awake-Regional Anaesthesia in Infancy” [GAS]2 and “Pediatric Anesthesia Neurodevelopment Assessment” [PANDA]3) which found that brief exposures to anesthesia in young children did NOT lead to neurocognitive dysfunction.  Specifically, a single, short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior and/or learning.  However, the question of long-term neurocognitive dysfunction remains an area of clinical concern.  Clearly, more research is required to fully understand how anesthetics might affect brain development.

The FDA is now requiring warnings to be added to the labels of general anesthetic and sedation drugs.  They have also advised health care professionals to carefully weigh the potential risk vs. benefit of anesthesia exposure in young children and pregnant women when providing care to these patients.

David Mirsky MD

Children’s Hospital Colorado, Aurora, CO


  1. https://www.fda.gov/Drugs/DrugSafety/ucm532356.htm
  2. Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, et al. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet 2016;387:239-50.
  3. Sun LS, Li G, Miller TL, Salorio C, Byrne MW, Bellinger DC, et al. Association between a single general anesthesia exposure before age 36 months and neurocognitive outcomes in later childhood. JAMA 2016;315:2312-20.

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