Repeated or lengthy use of general anesthesia may harm children’s brain development, the FDA warns. General anesthesia or sedation use in children under 3 may impact their developing brains, the FDA warned in a statement. WSJ’s Sumathi Reddy and the Mayo Clinic’s Dr. David Warner discuss on Lunch Break with Tanya 

 

Some pediatricians are concerned that parents may delay important surgeries for their children after the FDA last week warned that certain uses of general anesthesia or sedation drugs in young children may harm brain development.

 

The warning focused on repeated use of general anesthesia in children under 3 years old, or a one-time use during surgery that lasts three hours or more. The Food and Drug Administration warning also applies to pregnant women in their third trimester.

 

Recent studies have found that a single use of anesthesia for a short period is unlikely to have negative effects, the FDA noted in its warning.

 

More than one million children a year in the U.S. under the age of 4 have surgeries that require anesthesia, according to the FDA. Only about 20% of those end up needing it again while they are still young, and even fewer children undergo surgeries that are three hours or longer, says David Warner, a pediatric anesthesiologist and professor of anesthesiology at the Mayo Clinic, in Rochester, Minn.

 

The majority of parents can be reassured about general anesthesia, says Dr. Warner, who expects many more parents of young children will have questions for him about its use.

 

General anesthesia is often used in children for tonsillectomies, placing of ear tubes and some gastrointestinal procedures -- surgeries that generally last less than two hours.

 

For longer surgeries, such as fixing a congenital heart problem, or repairing a cleft lip, which usually requires multiple operations, Dr. Warner says he already discusses with parents the potential negative impact of general anesthesia.

 

Randall Flick, president of the Society for Pediatric Anesthesia and a director of the Mayo Clinic Children’s Center, says the society worries that the FDA warning “may cause undue concern,” given that there are no clear alternatives to general anesthesia for certain surgeries.

 

“Parents and clinicians should be cautioned that delays in needed procedures may have unintended negative consequences,” Dr. Flick says.

 

The safety of general anesthesia in young children has been a vexing question for decades. Animal studies have found that general-anesthetic use kills nerve cells in the brain, which can cause learning, memory and behavioral problems later.

 

Several recent studies involving children have found that a single, brief exposure to general anesthesia is unlikely to have a negative impact on learning or behavior. But most studies looking at repeated or lengthy exposures have found negative effects on later learning and behavior.

 

Some families request doing local anesthesia, if possible, because of concerns they’ve heard about general anesthesia, says Santhanam Suresh, chairman of pediatric anesthesiology at Ann & Robert H. Lurie Children’s Hospital of Chicago. For example, spinal anesthetics are sometimes used for hernia repairs in young children, says Dr. Suresh, who is also co-chairman of SmartTots, a nonprofit group formed by the FDA and International Anesthesia Society to promote research on the effect of general anesthesia on young children.

 

The FDA is requiring warnings to be added to the labels of 11 general anesthetic and sedation drugs. The agency says further research is needed to determine how early anesthetic exposure affects children’s brain development.

 

A challenge for researchers is that it is nearly impossible to conduct a randomized, controlled trial on general anesthesia and to prove that anesthesia is the cause of something that may not be apparent until years later. Another problem: Most human studies have relied on existing outcomes collected for other purposes, like school test scores.

 

Dr. Warner, of the Mayo Clinic, says he is nearing completion of a four-year study he hopes will help resolve some questions. The study is using a number of neuropsychological tests, including videogames, to see if exposure to anesthesia is associated with a particular pattern of injury to brain cells.

 

The study involves some 1,000 children, 7 to 20 years old, about half of whom were exposed to general anesthesia one or more times at a young age. Results are expected to be published next year.

.The Wall Street Journal