The Food and Drug Administration on Wednesday issued a warning that repeatedly giving general anesthesia or sedatives to children under the age of 3 or pregnant women in their third trimester could harm a child’s brain development.
In a new Drug Safety Communication, the FDA wrote that it was requiring warnings to be added to the labels of general anesthetic and sedative drugs, recognizing the negative risks they pose to the developing brains of children. The drugs are given to young children when they undergo surgeries or other medical procedures for which anesthesia or sedatives are necessary — and the same goes for pregnant women who also require the drugs for procedures.
Through recent human studies, the FDA found that a single, relatively short dose of these drugs is unlikely to have negative effects. However, published animal studies show that repeated or prolonged exposure to these drugs in pregnant animals and young animals could lead to the widespread loss of nerve cells in the brain. Some studies conducted on children support the animal studies’ results, according to the Drug Safety Communication.
“We recognize 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,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation Research, said in a statement.