In December 2016, the Food and Drug Administration (FDA) issued a drug safety communication about general anesthesia and sedation in children aged three years or younger. The FDA is requiring the addition of warning labels on common anesthetics agents used for general anesthesia and sedation, due to research findings that suggest these medications may impact brain development in young children.
These warning labels are not “black box" warnings.* Rather, they serve as a reminder for doctors – specifically, pediatric surgeons and anesthesiologists – to discuss potential long-term effects that may be associated with these agents with parents.
There has been ongoing research examining the link between anesthesia and brain development for more than two decades, and more investigation is necessary to fully understand the potential risks. Results of recent studies imply that young patients who need long surgeries (more than three hours) or multiple surgeries before the age of three might be at risk for learning or behavioral issues later in life.
The reassuring news is that recent human studies indicate that a brief, single exposure to anesthesia in this age group does not have a negative impact on future cognitive ability. In addition, scientists have recognized two classes of medication that can be used for anesthesia that do not appear to have an impact on developing brains.
Your surgical team understands the decision to proceed with surgery or sedation is made after weighing all the benefits and risks, and that some procedures are necessary while a patient is younger than three years. At HSS, we are committed to limiting the amount of general anesthesia medications given to this age group.
While we may not always be able to avoid these medications, we can minimize them by using regional anesthesia whenever possible and by using the classes of medications that have been deemed safer for this age group. However, because of intraoperative clinical decisions, we can never rule out the possibility that one of these medications included in the FDA warnings may be used during your child’s surgery.
The FDA is encouraging physicians to discuss this topic with any parent who has a young child undergoing anesthesia or sedation. If you are a parent who is considering surgery for your child at HSS, please feel free to ask your surgeon, pediatrician or anesthesiology any questions.
* Note: A "boxed warning" or "black box warning" is, in the United States, the strictest prescription drug warning label required by the US Food and Drug Administration (FDA). The FDA requires pharmaceutical makers to apply these warnings on any prescription drug in which medical studies have demonstrated a significant associated health risk.