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FDA Anesthesia Warning for Pregnant Women, Children

Stockwell, Serena

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AJN, American Journal of Nursing: April 2017 - Volume 117 - Issue 4 - p 18
doi: 10.1097/01.NAJ.0000515223.23086.fc
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Abstract

The Food and Drug Administration (FDA) warned in December 2016 about the use of general anesthesia and sedation drugs in young children and pregnant women, particularly those in the third trimester. The alert urged caution about repeated or lengthy use, saying that further research is needed about the effects of the drugs on the developing brain. Still, the agency noted that lifesaving surgery should not be delayed, that risks should be weighed against benefits, and that the FDA would continue to monitor the situation and make further updates as needed.

Both the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP), however, objected, saying that because the existing research was done only in animals, the clinical significance remains unknown and the statement could discourage surgery if needed during pregnancy or for very young children.

Both AAP and ACOG also pointed clinicians to the ongoing SmartTots program (http://smarttots.org), focused on increasing the safety of anesthetic and sedative drugs for children. Visit http://bit.ly/2kFWrBx, http://bit.ly/2kA9Eth, and http://bit.ly/2kA6GEQ.—Serena Stockwell

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