FDA issues warning on use of general anesthetic and sedation drugs in children

The Food and Drug Administration has issued a Drug Safety Communication warning health care providers, parents and caregivers of children under the age of three that the repeated or prolonged use of general anesthetic and sedation drugs may adversely impact their developing brains. The agency defines prolonged use as more than three hours. FDA is requiring manufacturers to add warnings to the labels of such drugs. Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, said that the agency “recognize[s] that in many cases these exposures may be medically necessary and these new data regarding the potential harms must be carefully weighed against the risk of not performing a specific medical procedure.”