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Behind the Black Box: The Evidence for the U.S. Food and Drug Administration Warning about the Risk of General Anesthesia in Children Younger than 3 Years

Derderian, Christopher A. M.D.; Szmuk, Peter M.D.; Derderian, Courtney K. M.D.

Plastic and Reconstructive Surgery: October 2017 - Volume 140 - Issue 4 - p 787-792
doi: 10.1097/PRS.0000000000003691
Pediatric/Craniofacial: Special Topics
Video Discussion
Press Release

Summary: On December 14, 2016, the U.S. Food and Drug Administration issued a Drug Safety Communication warning “that 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.” Health care professionals were urged to “balance the benefits of appropriate anesthesia in young children and pregnant women against the potential risks, especially for procedures that may last more than 3 hours or if multiple procedures are required in children under 3 years.” Surgeons must have an understanding of the evidence that led to the U.S. Food and Drug Administration warning and recommendations to appropriately weigh these risks and counsel their patients. In this article, the authors summarize the preclinical and clinical data that led to the U.S. Food and Drug Administration warning, discuss ongoing clinical studies, and provide strategies to reduce the risk of general anesthesia in patients younger than 3 years.

Video Discussion by Larry Hollier, M.D., is Available Online for this Article.

Dallas, Texas

From the Departments of Plastic Surgery and Anesthesia, University of Texas Southwestern Medical Center.

Received for publication February 18, 2017; accepted March 28, 2017.

Disclosure:The authors have no financial disclosures related to the content of this article.

A Video Discussion by Larry Hollier, M.D., accompanies this article. Go to and click on “Video Discussions” in the “Digital Media” tab to watch.

Christopher A. Derderian, M.D., Department of Plastic Surgery, University of Texas Southwestern Medical Center, 1801 Inwood Road, Dallas, Texas 75390,

Copyright © 2017 by the American Society of Plastic Surgeons