[ANESTHETIC DRUGS IN CHILDREN AND PREGNANT WOMEN - IMPLICATIONS OF THE RECENT FDA WARNING].

Recent animal studies demonstrated neuronal apoptosis following early life exposure to most anesthetic drugs. Further research into this question demonstrated neonatal neuronal damage in multiple species (including primates) and evidence that this damage has cognitive and social sequela. These results raised the suspicion that general anesthesia in neonates, infants and pregnant women may injure the developing brain. Follow-up human studies were inconclusive. Retrospective studies suffer from tremendous selection bias due to the surgical effect and the baseline condition that required the surgical intervention. A number of large retrospective studies yield contradicting results, leaving the issue unsettled. Results of new, high quality prospective studies suggest that a short, single exposure does not lead to any measurable damage, but we are still awaiting final long term results. Despite the inconclusive evidence, the American Food and Drug Administration (FDA) published a warning mandating drug manufacturers to disclose the risk with the package insert, and clinicians to discuss the possible risks with the parents or the pregnant woman before the planned procedure. The European Society of Anesthesiologists, as well as the Israeli Society of Anesthesiologists, did not adopt this FDA policy. Despite the possible uncertain risk, it was decided that the evidence is inconclusive in regards to clinical human scenarios. It was agreed that such warnings would lead to delaying necessary procedures based on unfounded information. It was therefore decided to avoid changing the informed consent form and consent process until further information is available.