VOLUME 29, ISSUE 2
Priscilla J. Garcia, MD, MHA
Pediatrics Editor
Assistant Professor, Department of Anesthesiology,
Perioperative & Pain Medicine, Baylor College of Medicine
Texas Children’s Hospital
Houston, TX
Parental Notification Of The FDA Warning On Anesthesia And The Developing Brain
With little warning, the United States Food and Drug Administration (FDA) released a Drug Safety Communication on December 14, 2016 that stated, “repeated or lengthy use of general anesthetic or sedation drugs during surgeries or procedures in children younger than three years of age or in pregnant women during the final trimester may affect development of children’s brains.” The FDA defined lengthy as longer than 3 hours of anesthetic exposure. Labels on general anesthetic and sedation drugs would now have this safety warning. The FDA acknowledged that “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.”
Per the FDA, they have been investigating the potential adverse effects of general anesthetic and sedation drugs on children’s brain development since the first animal study on this subject was published in 19991. They have held three separate advisory committee meetings and have formed a partnership with the International Anesthesia Research Society (IARS) called SmartTots.
This warning was intended by the FDA to raise awareness among practitioners and the public so that information needed to make an informed decision about the risks and benefits of anesthesia and sedation in young children and pregnant women would be available. The FDA released an updated statement on April 27, 2017 expressing its previously announced warning but reiterating that surgeries and procedures that are medically necessary should not be delayed or avoided in these populations. They further detailed that studies in young and pregnant animals showed that exposure to general anesthetic or sedation drugs for more than 3 hours can “cause widespread loss of nerve cells in the developing brain; and studies in young animals suggested these changes resulted in long-term negative effects on the animals’ behavior or learning.”
The Society for Pediatric Anesthesia (SPA) issued a consensus statement along with several other societies including the American Academy of Pediatrics, the American Society of Anesthesiologists, IARS, Society for Maternal Fetal Medicine,
Society for Obstetric Anesthesia and Perinatology and others in response to the FDA Med Watch on December 2016 acknowledging the FDA warning but cautioning against the possible risk of delaying needed surgical or diagnostic procedures. They advocated that parents and providers weigh the risk and benefit of each contemplated procedure prior to proceeding. Texas Children’s Hospital spearheaded the development of an information sheet that may be given to parents informing them of the facts regarding this new warning. See attached pdf. Our current practice is that for those patients who would likely fall into the affected demographic, the discussion starts in the surgeon’s office. The discussion is continued by the anesthesiologist on the day of surgery.
For those interested in learning more information, Dean Andropoulos, MD, MHCM, Anesthesiologist-In-Chief at Texas Children’s Hospital will be giving a detailed presentation on this topic along with insights into the new anesthesia consent form at the TSA Annual Meeting Pediatric Parallel Session on September 8, 2017. ♦
The complete FDA statement can be found at:
http://www.fda.gov/Drugs/DrugSafety/ucm532356.htm?source=govdelivery&utm_medium=email&utm_sour ce=govdelivery
Additional information can also be found on the SmartTots website: www.smarttots.org.
Link to the pdf of the handout “Anesthesia and Brain Development in Your Child.”
Reference:
1. Ikonomidou C, Bosch F, Miksa M, Bittigau P, Vockler J, Dikranian K, et al. Blockade of NMDA receptors and apoptotic neurodegeneration in the developing brain. Science 1999; 283:70-4.
