Product News and Recalls

FDA Cautions Against Excessive Anesthesia for Young Children

fda warns on anesthetics in childrenThe FDA is now requiring 11 anesthetic and sedation drugs to carry additional warnings on their labels because their extended use in young children might lead to brain damage. The warnings will apply to children aged three years and younger, as well as pregnant women in their third trimester.

Concern has slowly grown over using anesthetics during critical periods of brain development. Repeated use, as well as single sessions lasting longer than three hours, pose particular risks. A STAT News report details how animal studies have indicated how the drugs can cause weakened connections between brain cells, or even cell death. Impaired or decreased numbers of brain cells can lead to learning and behavioral disorders, like ADHD and memory loss.

The first study on the risks of repeated exposure to anesthesia was conducted on rats. They ended up with “long-term abnormalities in their behavior,” according to the New York Times. Since then, studies on monkeys and young children have yielded similar results. It is not yet known whether this brain damage is reversible, thus giving further reason for medical professionals and parents to be uneasy.

FDA and other experts are encouraging doctors and parents to postpone procedures that use anesthesia in children three and younger if at all possible. The New York Times poses the question of “what surgery can be reasonably delayed?” So far, in response, doctors are reluctant to state any exact procedures that could be put off.

This concern hasn’t grown simply because of findings uncovered in the last two decades. More than one million children in the U.S. under the age of four will undergo medical procedures that require anesthesia ever year. Research results to this point haven’t indicated a causal relationship between overexposure to anesthetics and brain damage in youths. But the FDA’s actions now show that enough data exists to take the issue seriously.

The FDA urges parents and guardians to speak with their child’s medical professionals about the details and potential risks of using anesthesia in any upcoming procedures; sound advice given that half of all surgeries may already involve at least some error in medication levels or types. Results of ongoing research into the effects of anesthetics on children might not be available for years, meaning millions of caregivers will potentially need to make decisions regarding the care of these children without all ascertainable information. In the meantime; parents, guardians, and the medical community are encouraged to make their decisions based on the best scientific information available at the time.