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November 2017

Anesthesia Exposure and Neurotoxicity in Children—Understanding the FDA Warning and Implications for the Otolaryngologist

Author Affiliations
  • 1Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas
  • 2Department of Anesthesiology, Children’s Medical Center Dallas, Texas
  • 3Division of Pediatric Otolaryngology, Department of Otolaryngology–Head and Neck Surgery, University of Texas Southwestern, Dallas
  • 4Outcomes Research Consortium, Cleveland, Ohio
JAMA Otolaryngol Head Neck Surg. 2017;143(11):1071-1072. doi:10.1001/jamaoto.2017.1570

Over the past decade, a large body of evidence has suggested that there may be an association between anesthesia exposure and neurocognitive deficits in children. The majority of data are derived from animal studies, but some human studies support an association between single or multiple anesthesia exposures in young children and cognitive deficits.1 With the exception of a recent prospective study and a recent ambidirectional study,2,3 human studies are limited to retrospective cohort studies that lack adequate controls or attention to the impact of confounding variables. On December 14, 2016, the US Food and Drug Administration (FDA) issued the warning 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.”4