FDA: Use of General Anesthetics, Sedatives May Harm Young Children

Children’s brain development may be adversely affected by the use of general anesthetic and sedation drugs, the FDA said in a warning statement. A warning about the risks will be added to the labels of these drugs.

The negative impact on brain development may occur from the third trimester of pregnancy up to approximately 3 years of age in children who are repeatedly exposed to anesthetics or exposed for a long period of time (3 or more hours).

Shorter, one-time exposure to general anesthetic or sedation drugs is unlikely to pose a risk. “Consistent with animal studies, recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. However, further research is needed to fully characterize how early life anesthetic exposure affects children’s brain development,” the FDA stated.

The warning statement is based on data from animal studies that indicate that use of general anesthetic and sedation drugs for longer than 3 hours led to widespread loss of nerve cells in the brain. Studies in children support some of these findings, especially those regarding repeated or prolonged exposure early in life, but the studies had limitations.

The FDA acknowledged that these drugs are sometimes necessary when surgery or other painful, stressful procedures are required. Nonetheless, the agency recommends that clinicians evaluate the risks and benefits of anesthesia in young children and in pregnant women. The risk is particularly concerning in procedures with a duration of 3 or more hours or if multiple procedures are needed in children younger than 3 years of age. “Discuss with parents, caregivers, and pregnant women the benefits, risks, and appropriate timing of surgery or procedures requiring anesthetic and sedation drugs,” the FDA said.

—Lauren LeBano

Reference

FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women. Silver Spring, MD: U.S. Food and Drug Administration; December 14, 2016.