Use of general anesthesia or sedation drugs should be avoid in pregnant women who are late in their pregnancy and children less than the age of 3 since use can lead to learning deficits and could harm developing brains in unborn babies and young children.
The Drug Safety Communication issued Dec. 14 by the FDA noted the new warnings indicating this risk must be added to the label of general anesthetic and sedating medications.
“We recognize that in many cases these exposures [to anesthesia] 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,” Director of the FDA’s Center for Drug Research and Evaluation, Janet Woodcock, MD, said in a statement.
The FDA has been investigating this issue since at least 2013 when the agency announced it was working with the International Anesthesia Research Society to determine if anesthesia causes long-term learning deficits in children and pregnant woman.
