Πέμπτη 1 Ιουνίου 2017

[Comment] 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 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.

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