The US Food and Drug Administration (FDA) has released a warning to inform clinicians, parents and caregivers of children younger than 3 years of age, and pregnant women in their third trimester that the repeated or lengthy use of general anesthetic and sedation drugs during surgeries may affect the development of children’s brains.
Recent data have shown that a single, relatively short exposure to general anesthetic and sedation drugs in infants is unlikely to have adverse effects on behavior or learning, but further research is needed to determine how early in life anesthetic exposure affects the development of a child’s brain.
“To better inform the public of the risks, we are requiring warnings to be added to the labels of these drugs,” stated Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “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.”
The FDA notes that healthcare professionals should balance the benefits and potential risks of appropriate anesthesia in children and pregnant women, especially for procedures that will last more than 3 hours or for multiple procedures that are required in children younger than 3 years of age.
In addition, parents and caregivers should discuss the potential adverse effects of anesthesia with their child’s healthcare professional, as well as the appropriate timing of procedures that can be delayed without jeopardizing their child’s health. Pregnant women should also discuss the potential adverse effects of anesthesia with their healthcare professionals.
Studies conducted in pregnant animals and young animals have shown that the general use of general anesthetic for more than 3 hours has caused loss of nerve cells in the brain. Some studies conducted in children support findings from the studies conducted with animals, particularly after repeated or prolonged exposure to anesthesia later in life. However, more research is required to provide additional information about the safety of these drugs in young children and pregnant women.
The FDA is urging healthcare professionals, patients, parents, and caregivers to report side effects involving anesthetic and sedation drugs to the FDA MedWatch program.
- US Food and Drug Administration. FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women [press release]. Published December 14, 2016. Accessed December 16, 2016.
- US Food and Drug Administration. FDA statement from Dr Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, on new safety information on anesthesia use in young children and pregnant women [press release]. Published December 14, 2016. Accessed December 16, 2016.