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Anesthesia Exposure in Children

Practitioners Respond to the 2016 FDA Drug Safety Communication

Pinyavat, Teeda, MD*; Saraiya, Neeta R., MD*; Chen, Jerri, MD, PhD*; Ferrari, Lynne R., MD; Goffman, Dena, MD; Imahiyerobo, Thomas A., MD§; Middlesworth, William, MD§; Hyman, Joshua E., MD; Hyun, Grace, MD; Houck, Constance S., MD, MPH

Journal of Neurosurgical Anesthesiology: January 2019 - Volume 31 - Issue 1 - p 129–133
doi: 10.1097/ANA.0000000000000545
Supplement: Proceedings of the Sixth PANDA Symposium on “Anesthesia and Neurodevelopment in Children

In December 2016, the US Food and Drug Administration (FDA) issued a drug safety warning stating that 11 commonly used anesthetic and sedative medications had potential neurotoxic effects when used in children under the age of 3 years and in pregnant women during the third trimester. A panel presentation at the sixth biennial Pediatric Anesthesia Neurodevelopmental Assessment (PANDA) symposium addressed the FDA announcement in a session entitled “Anesthesia Exposure in Children During Surgical and Non-Surgical Procedures: How Do We Respond to the 2016 FDA Drug Safety Communication?” Panelists included representatives from pediatric anesthesiology, obstetrics, pediatric surgery, and several pediatric surgical subspecialties. Each panelist was asked to address the following questions: How has the FDA labelling change affected your clinical practice including patient discussions, timing, and frequency of procedures? Has your professional society provided any guidelines for this discussion? Has there been any discussion of this topic at your national meetings? The panelists provided important perspectives specific to each specialty, which generated a lively discussion and a detailed response from the Deputy Director of the Division of Anesthesia and Addiction of the FDA describing the FDA procedures that led to this drug safety warning.

Departments of *Anesthesiology

Obstetrics and Gynecology


Orthopedic Surgery, Columbia University Irving Medical Center

Department of Urology, New York University Langone Health, New York, NY

Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children’s Hospital, Boston, MA

The authors have no funding or conflicts of interest to disclose.

Address correspondence to: Teeda Pinyavat, MD, Columbia University Irving Medical Center, CH 4-440 North, 622 West 168th Street, New York, NY 10032 (e-mail:

Received September 5, 2018

Accepted September 7, 2018

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