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 consent.
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.