April 21, 2015

Neurotoxicity of Generic Anesthesia Agents in Infants and ChildrenAn Orphan Research Question in Search of a Sponsor

Author Affiliations
  • 1Departments of Medicine and Epidemiology, Cardiovascular Health Research Unit, University of Washington, Seattle
  • 2Group Health Research Institute, Group Health Cooperative, Seattle, Washington
  • 3Harvard Medical School, Boston, Massachusetts
  • 4Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts
  • 5Department of Bioengineering, Stanford University, Stanford, California
  • 6Department of Genetics and Medicine, Stanford University, Stanford, California

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JAMA. 2015;313(15):1515-1516. doi:10.1001/jama.2015.1149

Millions of neonates and toddlers undergo anesthesia or sedation for surgeries and procedures each year. At the same time, mounting evidence from controlled studies in young animals suggests that anesthetic agents, administered during vulnerable periods, have neurotoxic effects that result in long-lasting deficits in learning and cognitive behavior. The relevance of these animal models to humans is unclear, and the available observational studies in children are limited. However, the possibility of harm exists. On November 19, 2014, the US Food and Drug Administration (FDA) Science Board, which provides advice to the FDA commissioner, was asked to evaluate whether the emerging data “are sufficient to conclude that the adverse effects noted in juvenile animals are reasonably expected to also occur in developing humans.”1

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