General Anesthetics, Sedatives, Can Affect Child Brain Development, FDA Warns

Federal regulators have announced new label warnings for general anesthetics and sedatives, indicating that repeat or long-term use by children or women late in pregnancy could have a detrimental effect on the child’s brain development. 

The FDA issued a drug safety communication on April 27, announcing the new label warnings, following years of research and a safety review.

In addition to the warning, the FDA is adding new information regarding a number of studies on children and pregnant women that bare out its concerns.

On December 14, 2016, the FDA issued a safety alert about the agency’s conclusions that repeated or lengthy use of general anesthetic or sedation drugs in children younger than three, or by pregnant women during the third trimester, could seriously affect child brain development. It was at that time that the agency announced that label changes would be coming in the future.

According to the agency’s findings, which will be added to the information section of the labels, “exposure to general anesthetic and sedation drugs for more than 3 hours can cause widespread loss of nerve cells in the developing brain,” with animal studies showing that this resulted in long-term detrimental effects on behavior and learning.

The new label warning will state that “exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years,” the FDA announced.

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.

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.

In 2015, 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 FDA acknowledged the need for general anesthetic and sedation drugs for patients, including young children and pregnant women. The agency stressed that these medically necessary surgeries should not be avoided or delayed when medically necessary. However, the FDA called for factoring in the anesthesia risk when considering elective surgery in young children.

The agency called for parents, caregivers and pregnant women to talk to their healthcare professionals about any questions or concerns about general anesthesia and sedation drugs. It recommended that health care professionals continue to discuss the risks and benefits of surgeries or procedures requiring general anesthesia and sedation with patients and caregivers.

The FDA said it will continue to monitor the use of general anesthetics and their effects on children, and urged any patients and healthcare professionals who experience side effects to report them to the FDA’s MedWatch adverse event reporting program.