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Sedation and The FDA 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: March 26, 2019 - Volume Publish Ahead of Print - Issue - p
doi: 10.1097/MPG.0000000000002346
Topic of the Month (Invited): PDF Only

ABSTRACT Pediatric gastroenterologists recommend and perform a range of procedures requiring sedation and anesthesia in young children. A recent warning from the US 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.

*Baylor College of Medicine, Texas Children's Hospital. Section of Pediatric Gastroenterology, Hepatology and Nutrition

MHCM; Baylor College of Medicine Department of Anesthesiology, Texas Children's Hospital Department of Anesthesiology

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

Address correspondence and reprint requests to Douglas S. Fishman, MD, 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

Disclosures; DSF is a contributor for UpToDate; DBA is a member of the SmartTots Advisory Board (public private partnership of FDA and International Anesthesia Research Society.; JRL is a speaker for Mead Johson and receives research grant funding from Abbvie.

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