Warnings: Young children, pregnant women

FDA warns about general anaesthesia/sedation for prolonged or repeated procedures in children under 3 and pregnant women in their 3rd trimester.
On December 14, the US Food and Drug Administration (FDA) issued a “Drug Safety Communication” and mandated warnings to be added to the labels of drugs commonly used for anaesthesia and sedation in children.

The safety communication warns over the use of drugs for general anaesthesia and sedation for prolonged (over three hours) or repeated procedures in children under three years old and pregnant women in their third trimester.

There is considerable evidence that several hours of exposure to general anaesthesia results in a variety of morphologic change in the developing brain in animal models. There is also some evidence that prolonged exposure may be associated with neurodevelopmental changes in some animal models. It is very unclear if these findings are relevant to humans. Human studies have provided mixed evidence.

Where an association was found between surgery and neurodevelopmental outcome, it is very unclear if this is due to the anaesthetic or the condition that warranted the anaesthetic. There is however increasing evidence to suggest that a single exposure of around an hour or less is not associated with any lasting neurodevelopmental changes. There are no human data to definitely determine the risk with longer anaesthetics.

The FDA warning advises caution with prolonged anaesthesia or sedation in pregnant women and young children. While it is reasonable to be prepared to discuss these issues with patients and families, without further evidence, this warning should have only a limited material impact on anaesthesia practice.

Children and pregnant women do not have prolonged anaesthesia for trivial reasons. There is inevitably significant benefit from the surgical procedure. Delaying or avoiding surgery may result in a significant and real risk of adverse outcome. There is also very good evidence that inadequate anaesthesia or analgesia can result in significant complications, and for prolonged procedures there is currently no evidence to suggest changing from established techniques would have an impact on long term outcome.

ANZCA and the Society for Paediatric Anaesthesia in New Zealand and Australia (SPANZA) are continuing to fund research to provide more data in this important area.

Professor Andrew Davidson
Editor in Chief, Pediatric Anesthesia

Dr David Linscott
President, SPANZA
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