New FDA Anesthetic and Sedation Drugs Warning

FDA says that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than three years or in pregnant women during their third trimester may affect development of children’s brains. An agency drug safety communication says 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. But, it says, further research is needed to characterize how early life anesthetic exposure affects children’s brain development.

The agency says it is requiring Warnings to be added to the labels of general anesthetic and sedation drugs, and will continue to monitor use of the drugs in children and pregnant women and will update the public if additional information becomes available.