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 (www.smarttots.org).
- 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
Previous Advisory Committee Meetings
2014 FDA Science Board
- CDER conversation 9/2014: http://www.fda.gov/Drugs/NewsEvents/ucm416597.htm
Consumer information pieces
- Anesthesia: Is it Safe for Young Brains? http://www.fda.gov/forconsumers/consumerupdates/ucm364078.htm
- SmartTots Aims to Make Anesthesia and Surgery Safer for Children Under Four http://www.fda.gov/drugs/resourcesforyou/ucm245926.htm
- Research Flash: FDA Scientists Study Pediatric Brain Function http://www.fda.gov/forconsumers/consumerupdates/ucm416286.htm
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Mellon RD, Simone AF, Rappaport BA (2007) Use of anesthetic agents in neonates and young children. Anesth Analg 104:509-520.
Rappaport B, Mellon RD, Simone A, Woodcock J (2011) Defining Safe Use of Anesthesia in Children. N Engl J Med 364:1387-1390.
Vutskits L (2012) Anesthetic-related neurotoxicity and the developing brain: shall we change practice? Paediatr Drugs 14:13-21.
Zhou Z, Ma D (2014) Anaesthetics-induced neurotoxicity in developing brain: an update on preclinical evidence. Brain Sci 4:136-149.