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Sedation and the Food and Drug Administration Warning

What a Pediatric Gastroenterologist, Hepatologist, and Pancreatologist Should Know

Fishman, Douglas S.*; Andropoulos, Dean B.; Lightdale, Jenifer R.

Journal of Pediatric Gastroenterology and Nutrition: July 2019 - Volume 69 - Issue 1 - p 3–5
doi: 10.1097/MPG.0000000000002346
Topic of the Month

ABSTRACT Pediatric gastroenterologists recommend and perform a range of procedures requiring sedation and anesthesia in young children. A recent warning from the US Food and Drug Administration (FDA) states that “repeated or lengthy use of general anesthetics 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.” 1 As it relates to time, the FDA warning details risks of “procedures lasting longer than 3 hours or if multiple procedures are required.” Pediatric gastroenterologists and related specialists should be aware of the warning and its relevance to their patients.

*Section of Pediatric Gastroenterology, Hepatology and Nutrition

Department of Anesthesiology, Baylor College of Medicine, Texas Children's Hospital, Houston, TX

Division of Pediatric Gastroenterology and Nutrition, Department of Pediatrics, University of Massachusetts School of Medicine, University of Massachusetts Memorial Children's Medical Center, MA.

Address correspondence and reprint requests to Douglas S. Fishman, MD, Section of Pediatric Gastroenterology, Hepatology and Nutrition, Texas Children's Hospital, Mark Wallace Tower 1000.10, 6701 Fannin Street, Houston, TX 70030 (e-mail:

Received 16 January, 2019

Accepted 10 March, 2019

D.S.F. is a contributor for UpToDate; D.B.A. is a member of the SmartTots Advisory Board (public private partnership of FDA and International Anesthesia Research Society; J.R.L. is a speaker for Mead Johson and receives research grant funding from Abbvie.

The authors report no conflicts of interest.

© 2019 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,