Federal health officials are warning that long or repeated exposure to anesthesia could cause long term damage to a child’s brain development.
In an FDA Safety Alert issued on December 14, the agency indicated repeated or lengthy use of general anesthetic or sedation drugs in children younger than three, or pregnant women during the third trimester, may seriously affect the development of children’s brains.
The safety alert indicates the agency will now require warnings to be added to the labels of general anesthetic and sedation drugs.
However, the FDA also found that recent studies showed little to no risk from relatively short exposures to general anesthetic and sedation drugs in infants or toddlers. Yet, they suggest further research is needed before reaching a definitive conclusion as to how anesthesia will affect a child’s brain development.
“The health of our nation’s children is a responsibility that the FDA takes very seriously,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement concerning the warning.
The FDA began investigating the effects of anesthesia in the first animal study in 1999 and held numerous advisory meetings in the years that followed. In 2013, the FDA announced the SmartTots joint research program to fund studies focusing on the effects of anesthesia in young children. However, a 2015 FDA report indicated even more research was needed to determine the risks of anesthesia to young children.
The agency acknowledges that anesthesia and sedation drugs are necessary for patients undergoing surgery or necessary medical procedures, but recognized there are serious risks linked to offering children under three years old or pregnant women anesthesia or sedation drugs.
Woodcock said anesthesia “may adversely affect children’s developing brains” and warned the “potential benefits must be carefully weighed against the risk of not performing specific medical procedures.”
A number of studies in recent years have warned of varying negative effects of anesthesia on children’s developing brains.
A 2012 study linked anesthesia during childhood to an increased risk of ADHD later in life.
A study published in 2013 indicated anesthesia may cause children under the age of three to develop memory and learning disorders, as well as behavioral problems, from widespread neurotoxicity.
Last year, a study published in the journal Pediatrics indicated anesthesia was linked to an increased risk of suffering impaired brain development in young children who had procedures before the age of 4. Those children had lower IQ scores and lower scores on listening comprehension tests.
The agency urges doctors to discuss the benefits and potential risks of anesthesia and sedation drugs on children’s brains with parents before a procedure that may last longer than three hours, or if the child will undergo multiple procedures.
The FDA said it was committed to monitoring the use of the drugs in children and pregnant women and will continue to update the public if more information becomes available.