FDA: New Warning for Anesthetic/Sedative Use in Children, Pregnant Women

Since 1999, the FDA has been evaluating the potential adverse effects of general anesthetics and sedatives on children's brain development.

The Food and Drug Administration (FDA) issued a warning that repeated or lengthy use of general anesthetics and sedatives during surgeries or procedures in children aged <3 years or in pregnant women during their 3rd trimester may affect the development of children’s brains.

Since 1999, the FDA has been evaluating the potential adverse effects of general anesthetics and sedatives on children’s brain development with advisory committee meetings held in 2007, 2011, and 2014. 

In published juvenile animal studies, the use of anesthetic and sedation drugs that block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity for longer than 3 hours has been shown to increase neuronal apoptosis in the brain resulting in long-term cognitive deficits . Recent human data suggest that a single, relatively short exposure to these drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. More studies are needed, however, to better characterize how early life anesthetic exposure affects brain development in children. 

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As a result, the FDA has required labeling updates for general anesthetic and sedation drugs to include these warnings. No specific anesthetic or sedation drug has been shown to be safer than any other.

Drugs affected by this label change include:

  • desflurane (Suprane)
  • etomidate (Amidate)
  • halothane
  • isoflurane (Forane)
  • ketamine (Ketalar) 
  • lorazepam injection (Ativan) 
  • methohexital (Brevital)
  • midazolam injection, syrup
  • pentobarbital (Nembutal)
  • propofol (Diprivan)
  • sevoflurane (Ultane, Sojourn)

The FDA safety communication recommends healthcare professionals consider the benefits vs. risks of the procedure when deciding the timing of elective procedures that require anesthesia. Also, healthcare professionals should discuss with patients, caregivers, and pregnant women the the benefits, risks, and appropriate timing and duration of surgery or procedures requiring anesthetics and sedatives, as well as the risks of not treating certain conditions. 

The FDA is continuing to monitor the use of these medications in children and pregnant women and will update the public as more information becomes available. 

For more information visit FDA.gov.