The U.S. Food and Drug Administration in late 2016 issued a safety communication that said that the FDA was “warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.”
The warning also states that “additional high-quality research is needed to investigate the effects of repeated and prolonged anesthesia exposures in children, including vulnerable populations.”
Until reassuring new information from well-designed clinical trials is available, we are concerned that the FDA warning will cause delays for necessary surgical and diagnostic procedures that require anesthesia, resulting in adverse outcomes for patients. We would urge parents, patients, and physicians to carefully consider the risks of delaying indicated procedures.