The Food and Drug Administration (FDA) has approved the label changes regarding the use of general anesthetic and sedation drugs in children aged <3 years. As previously announced, the major changes include a new warning and additional data under the pregnancy and pediatric use sections.
The new warning states that exposure to these drugs for lengthy periods of time or over multiple surgeries or procedures may have a negative effect on brain development in children aged <3 years.
The updates to the pregnancy and pediatric use sections include studies conducted in young animals and pregnant animals that showed widespread loss of nerve cells in the developing brain after exposure to general anesthetic and sedation. Findings also suggest that these changes may lead to long-term negative effects on the young animals’ behavior or learning.
General anesthetics and sedatives are intended for use in patients who need to undergo surgery or other procedures. For pregnant women, the FDA is advising to not delay or avoid surgeries or procedures during pregnancy, as it may negatively impact the infants or themselves. For children aged <3 years, the FDA is also advising to not delay or avoid surgeries or procedures when medically necessary. Delaying elective surgery may be considered where medically appropriate.
Healthcare professionals are encouraged to continue their standard practice of patient counseling to discuss the benefits and risks of surgeries or procedures that require general anesthetics and sedatives.
The FDA is continuing to track these medicines in children and will release updates if new data become available.
For more information visit FDA.gov.