Response to the FDA Med Watch December 16, 2016
December 16, 2016 01:11 PM
On Wednesday, December 14, the United States Food and Drug Administration (FDA) released a Drug Safety Communication warning that; "repeated or lengthy use of general anesthetic or sedation drugs during surgeries or procedures in children younger than three 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.
While there is abundant animal data concerning suspected toxicities in prolonged and multiple anesthetics, the accumulated human data suggest that one brief anesthetic is not associated with cognitive or behavioral abnormalities in children. Most but not all studies in children do however suggest an association between repeated and or prolonged exposure and subsequent difficulties with learning or behavior. It is not yet known whether the anesthetic drug or some other factor is responsible for these findings. Rigorous research to further characterize any possible associations is ongoing. Click here for full statement