AAP responds to FDA warning on anesthesia use in children
Raeford E.Brown Jr., M.D., FAAP and RitaAgarwal, M.D., FAAP
The Academy has coordinated a response to a recent Food and Drug Administration (FDA)
warning that cautions health care practitioners about the possibility of developmental
problems associated with repeated or prolonged use of anesthetics in children younger
than 3 years of age. The agency is requiring warning labels on all anesthetic agents
and sedatives, including propofol, midazolam and all volatile anesthetic agents.
An FDA Drug Safety Communication highlights the abundant animal data from more than
a decade concerning suspected toxicities when these agents are used during surgeries
or procedures lasting longer than three hours or when administered multiple times
to children younger than 3 and pregnant women in their third trimester. Laboratory
studies of multiple species, including primates, demonstrate that prolonged use and
multiple anesthetics or sedations have been associated with developmental anomalies
of cognition and memory and cell death in the developing brain.
The findings cited in the warning are not new. They have been discussed by three FDA
advisory committees since 2007. However, concerns have arisen recently that not all
practitioners using these medications for sedation or surgical anesthesia in children
are aware of these findings, reducing their ability to make informed decisions concerning
the risks and benefits of procedures requiring sedation or anesthesia. In addition,
lack of awareness reduces the clinician’s ability to educate families and get informed
The Academy, led by the Section on Anesthesiology and Pain Medicine and the Committee
on Drugs, coordinated a response that aimed to place this warning in the perspective
of recent controlled trials in humans and multiple epidemiological studies of large
homogeneous populations. These studies demonstrate no developmental problems in children
exposed to a single, short anesthetic or sedation.
The response cautions parents and clinicians of the risks of delaying needed surgery
and diagnostic procedures. Until additional information is available from the many
ongoing studies in animals and humans, parents and providers should weigh the risks
and benefits of each contemplated procedure prior to proceeding.
In addition to the Academy, numerous other professional organizations endorsed the
response, including the American Society of Anesthesiologists, the International Anesthesia
Research Society, Society for Obstetric Anesthesia and Perinatology, Society for Pediatric
Anesthesia, Congenital Cardiac Anesthesia Society, Pediatric Anesthesia Leadership
Council and the Society for Pediatric Pain Medicine.
Dr. Brown is chair-elect and Dr. Agarwal is chair of the AAP Section on Anesthesiology
and Pain Medicine Executive Committee.