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On 14 December 2016, the US Food and Drug Administration (FDA) issued a warning that the repeated or lengthy use of general anaesthetic and sedative drugs in children under 3 years old and in pregnant women in their third trimester may affect the development of children’s brains. Warning labels were required to be added to general anaesthetic and sedative drugs.1 Data from published studies in pregnant and young animals have shown that the use of general anaesthetics increases the chance of apoptosis and neurodegeneration in the developing brain. Persistent memory and learning disabilities have been demonstrated2,3 as well as increased severity with increasing duration of anaesthesia.4 Certain human studies suggest an association between anaesthesia and subsequent behaviour or learning issues such as autism, attention-deficit disorder, and language deficits.5-7 Some researchers postulate that even relatively simple anaesthesia of babies and young children can pose a risk of neurotoxicity. The question is whether or not we can translate such animal data to humans and to what extent we should interpret the animal findings.8 For many years well-designed human studies were lacking. Data were mainly observational and retrospective, and with too many confounding factors. There were often conflicting results in different studies.9,10 Recently, however, more robust human studies have been published such as General Anaesthesia compared to Spinal anaesthesia (GAS) study11 and Pediatric Anesthesia NeuroDevelopment Assessment (PANDA).12,13 The GAS study, which compares children less than 60 weeks’ post-gestational age (but older than 26 weeks’ post gestation) undergoing hernia surgery under either general anaesthesia or awake regional anaesthesia, has shown that at the 2-year mark (secondary outcome), there is no increase in risk of learning disability. This study is ongoing with its primary outcome being the Wechsler Preschool and Primary Scale of Intelligence Third Edition Full Scale Intelligence Quotient score at 5 years old. The PANDA study was a sibling-matched cohort observational study that examined whether anaesthesia exposure in healthy children younger than 3 years old is associated with an increased Hong Kong Med J 2017;23:433–4 DOI: 10.12809/hkmj176918 Silky Wong, FHKAM (Anaesthesiology), FANZCA, Theresa WC Hui *, FHKAM (Anaesthesiology), FANZCA

Response to the Food and Drug Administration warning on the use of anaesthetics in young children