On Wednesday, December 14, the United States Food and Drug Administration (FDA) released a Drug Safety Communication (www.fda.gov/Drugs/DrugSafety/ucm532356.htm) warning that “repeated or lengthy use of general anesthetic or sedation drugs during surgeries or procedures in children younger than 3 years of age or in pregnant women during the final trimester may affect development of children’s brains.” The FDA defined “lengthy” as greater than three hours of exposure.1,*

As a result, the FDA is requiring warnings to be added to the labels of general anesthetics and sedation drugs (Table 1). No specific anesthetic or sedation drug has been shown to be safer than any other, the FDA notes.

This label change is a regulatory action, not a black box warning, which are specifically designed to call attention to serious or life-threatening risks. In...

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