Warnings, uncertainty, and clinical practice

Paediatric anaesthetists in the USA and around the world were surprised in December, 2016, when the US Food and Drug Administration (FDA) issued a Drug Safety Communication warning that exposure to anaesthetic and sedative drugs for more than 3 h may cause adverse effects on the developing brain in...

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Bibliographic Details
Published in:The Lancet (British edition) 2017-06, Vol.389 (10085), p.2174-2176
Main Authors: Polaner, David M, Zuk, Jeannie, McCann, Mary Ellen, Davidson, Andrew
Format: Article
Language:English
Subjects:
Anesthesia
Anesthesiology
Anesthetics - administration & dosage
Anesthetics - adverse effects
Anxiety
Child, Preschool
Clinical decision making
Clinical trials
Cognitive ability
Communication
Decision making
Drug Administration Schedule
Drugs
Evidence-Based Medicine
Fetuses
Glutamate receptors
Humans
Hypnotics and Sedatives - administration & dosage
Hypnotics and Sedatives - adverse effects
Infant
Infant, Newborn
Infants
Internal Medicine
N-Methyl-D-aspartic acid receptors
Neurodevelopment
Neurodevelopmental Disorders - chemically induced
Neurology
Neurotoxicity
Patients
Pediatrics
Pharmacovigilance
Primates
Product safety
Regulatory agencies
Side effects
Synaptogenesis
Uncertainty
United States
United States Food and Drug Administration
Warning
γ-Aminobutyric acid
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Summary:Paediatric anaesthetists in the USA and around the world were surprised in December, 2016, when the US Food and Drug Administration (FDA) issued a Drug Safety Communication warning that exposure to anaesthetic and sedative drugs for more than 3 h may cause adverse effects on the developing brain in infants younger than 3 years and in the fetus during the third trimester.1,2 The data on which the public warning was based were well known to practitioners and academics, but release of the warning occurred without advance notice, resulting in considerable consternation among clinicians.3 Evidence from animal studies has accumulated in the past two decades that lengthy general anaesthesia or sedation, both with drugs interacting at the N-methyl-D-aspartate receptor and at the γ-aminobutyric-acid (GABA) A receptor, increased neuroapoptosis, altered synaptogenesis, and resulted in abnormal neurodevelopment and performance in many species, including non-human primates.
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(17)31506-4