Avoid extended anesthesia if possible in young children and pregnant women

Abstract

Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research, has issued new safety information on anesthesia use in young children and pregnant women. On Dec. 14, 2016, she issued a Drug Safety Communication (http://www.fda.gov/Drugs/DrugSafety/ucm532356.htm) to inform health care providers, parents, and caregivers of children younger than three years, and pregnant women in their third trimester, that the repeated or lengthy (more than three hours) use of general anesthetic and sedation drugs may adversely affect children's developing brains. Woodcock wrote, “To better inform the public of the risks, we are requiring warnings to be added to the labels of these drugs. We recognize that in many cases these exposures may be medically necessary and these new data regarding the potential harms must be carefully weighed against the risk of not performing a specific medical procedure. In 2010, the FDA formed a partnership with the International Anesthesia Research Society (IARS) called SmartTots (Strategies for Mitigating Anesthesia‐Related neuroToxicity in Tots) (http://smarttots.org) to fund additional research to better understand the safe use of these drugs in young children and pregnant women.”