FDA Advisory on Anesthesia and Sedation Medication in Children

What it Means for You

In December 2016, the FDA issued a Drug Safety Communication warning that “repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.” (http://www.fda.gov/Drugs/DrugSafety/ucm532356.htm) Animal studies indicate that prolonged or repeated exposure to anesthesia/sedation drugs causes neuronal loss with long-term changes in behavior and learning. Some of the studies with children have demonstrated similar results, though with study limitations and other possible causes for the developmental changes. The animal and human studies thus far indicate that one, relatively short exposure (<3 hours) is unlikely to adversely affect brain development.

It is important to keep in mind that studies have also shown that untreated pain is also harmful to children and their development, making anesthesia/sedation an important component of appropriate and indicated patient care. Further investigation is needed and ongoing to evaluate the potential effects of these medications on child brain development.

What does this mean for your practice and your patients?

  • Carefully weigh the risks and benefits of diagnostic and therapeutic procedures requiring sedation/anesthesia, particularly for procedures longer than 3 hours or if multiple procedures are considered in children under 3 years of age.
  • Discuss with caregivers the benefits, risks, timing, duration, and indication for the sedated procedure, as well as the risks of not performing or delaying it.
  • Consider delaying elective procedures if this will not adversely affect the child’s heath.
  • Judiciously consider what sedated tests you order. Is it necessary? Will the results change your patient care?

For more information:

FDA Website

SmartTots Website