Pediatric Anesthesia

Millions of children receive anesthesia and sedation drugs each year for surgeries and procedures; however, until recently, little was known about these drugs’ effects on the developing brain. Research studies have found that early exposure in juvenile animals to anesthetics and sedation drugs is associated with neurodegenerative changes in the developing brain. The FDA acknowledges that there are insufficient human data to determine the clinical relevance of these animal findings to pediatric patients. Therefore, additional non-clinical and clinical studies are needed to assess the effect of anesthetics and sedation drugs on the developing human brain, including long-term studies in neonates and young children. To further this research effort, FDA has collaborated with the International Anesthesia Research Society (IARS) to form a Public Private Partnership, SmartTots, under the Pediatric Anesthesia Safety Initiative (smarttots.org).

Latest Information

• FDA Drug Safety Communication: FDA approves label changes for use of general anesthetic and sedation drugs in young children
• FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women
• FDA Statement from Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, on new safety information on anesthesia use in young children and pregnant women