February 2017

Title: Anesthesia and Developing Brains —  Implications of the FDA Warning

URL: http://www.nejm.org/doi/pdf/10.1056/NEJMp1700196

DOI: 10.1056/NEJMp1700196

Published: 8th February 2017

Authors: Andropoulos DB, Greene MF

From the Paediatric and Congenital Committee

Study description and main objective:

On December 14, 2016, the FDA released a „Drug Safety Communication“ in which it is warned "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“ (http://www.fda.gov/Drugs/DrugSafety/ucm532356.htm).

In the article of the month, Dean B. Andropoulos and Michael F. Greene give their personal perspective on this FDA communication. Both authors are concerned due to several facts: 1) Human data on aesthetic-induced neurotoxicity are sparse and contradictory; 2) At least in congenital heart disease, the vast majority of anaesthetics in children < 3 years is performed for the treatment of life-threatening conditions. Postponing these interventions is not possible and alternatives are not available; 3) Likewise, safe alternatives to conventionally used anaesthetics (all of them have been demonstrated in animal experiments to impair brain development) are not available.

Clinical impact:

The statement of Andropoulos and Greene gives a brief consideration of the various strategies how to deal with the FDA warning concerning informed parental consent, preoperative planning, timing of the procedure etc. Most importantly, Andropoulos/Greene 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 “. Of note, the sequelae of untreated cardiac conditions (e.g., hypoxia or heart failure) are also important drivers for impaired neurodevelopment outcome.?


At current, delaying an interventional/surgical procedure for the treatment of a congenital cardiac condition seems to be more harmful than accepting the (potential) risk of aesthetic-induced neurotoxicity.

The question for everyone: Do you agree about that consensus?