Anesthesia might pose risks for children
FDA holds forum on animal studies
WASHINGTON -- Anesthesia can be harmful to the developing brain, studies on animals suggest, raising concerns about potential risks in putting young children under for surgery.
Food and Drug Administration scientists stressed yesterday they have no evidence that anesthesia and sedation drugs, commonly administered for decades, can cause brain damage in children.
But numerous animal studies find that a majority of the drugs typically used to anesthetize children before surgery do kill brain cells in young rats, mice, and -- preliminary results suggest -- rhesus monkeys.
"A safety signal has been identified in animals for many drugs used to provide sedation and anesthesia. . . . The relevance of the animal findings to pediatric patients is unknown," Dr. Arthur Simone, an FDA medical officer, told specialists the agency gathered to discuss the issue.
Experiments on laboratory rats and other animals have shown that the drugs can lead to subtle but prolonged changes in behavior, including memory and learning impairments, according to a study published by FDA scientists this month in the journal Anesthesia & Analgesia. Scientists do not know whether those findings apply to children, nor have comparable human studies been done that might provide answers.
Even detecting the effect of ketamine, halothane, and other anesthetics on the central nervous system is difficult if not impossible in the young, according to the FDA. Unlike, say, fetal alcohol syndrome, there is no clear-cut collection of disorders associated with anesthesia exposure, said Dr. Bob Rappaport, head of the FDA's anesthesia office and one of the study's authors. 