The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (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, we are 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). We will continue to monitor the use of these drugs in children and pregnant women and will update the public if additional information becomes available.
To learn more, please visit: general anesthetic and sedation drugs.