Recently the FDA released a statement associating general anesthesia for periods greater than 3 hours in children under 3 years of age or women pregnant in their third trimester with neurocognitive difficulties. In response to this notification, the American Academy of Pediatrics as well as the Anesthesia Section within the American Academy of Pediatrics responded with statements that judicious risk:benefit evaluations be taken on these children undergoing anesthesia. There are no data to support that a brief single anesthetic episode is associated with any neurocognitive delay. Additionally, for children who do require prolonged anesthesia, procedures are typically performed to correct or prevent a condition that has a much higher chance of harm. The child's care is ultimately it is up to the physician and the family to come up with the best plan and weigh the risks and benefits of any condition requiring anesthesia.
Below are several resources from the American Academy of Pediatrics and the FDA.
General Anesthetic and Sedation Drugs: Drug Safety Communication -New Warnings for Young Children and Pregnant Women
AUDIENCE: Consumer, Surgery, Anesthesiology
ISSUE: FDA is 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.
Consistent with animal studies, recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. However, further research is needed to fully characterize how early life anesthetic exposure affects children’s brain development.
To better inform the public about this potential risk, FDA is requiring warnings to be added to the labels of general anesthetic and sedation drugs (see List of General Anesthetic and Sedation Drugs Affected by this Label Change). FDA will continue to monitor the use of these drugs in children and pregnant women and will update the public if additional information becomes available.
See the FDA Drug Safety Communication for a data summary and listing of general anesthetic and sedation drugs affected by this label change.
BACKGROUND: Anesthetic and sedation drugs are necessary for infants, children, and pregnant women who require surgery or other painful and stressful procedures, especially when they face life-threatening conditions requiring surgery that should not be delayed. In addition, untreated pain can be harmful to children and their developing nervous systems.
FDA has been investigating the potential adverse effects of general anesthetic and sedation drugs on children’s brain development since the first animal study on this topic was published in 1999. FDA held advisory committee meetings in 2007, 2011, and 2014. To coordinate and fund research in this area, FDA also formed a partnership with the International Anesthesia Research Society (IARS) called SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots). More research is still needed to provide additional information about the safe use of these drugs in young children and pregnant women.
RECOMMENDATION: Health care professionals should balance the benefits of appropriate anesthesia in young children and pregnant women against the potential risks, especially for procedures that may last longer than 3 hours or if multiple procedures are required in children under 3 years. Discuss with parents, caregivers, and pregnant women the benefits, risks, and appropriate timing of surgery or procedures requiring anesthetic and sedation drugs.
Parents and caregivers should discuss with their child's health care professional the potential adverse effects of anesthesia on brain development, as well as the appropriate timing of procedures that can be delayed without jeopardizing their child’s health. Pregnant women should have similar conversations with their health care professionals. Also talk with them about any questions or concerns.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Download form or call pre-addressed.
News Articles, Anesthesiology/Pain Medicine, Surgery
AAP responds to FDA warning on anesthesia use in children
by Raeford E. Brown Jr. M.D., FAAP; Rita Agarwal 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 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.
AAP response to the FDA Drug Safety Communication
FDA Drug Safety Communication
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