Administrative Update  |   April 2017
The FDA Drug Safety Communication: What Does This Mean About Anesthesia Safety for Mothers and Children?
Author Affiliations
  • Linda J. Mason, M.D.
    ASA First Vice President
Article Information
Patient Safety / Pediatric Anesthesia / Administrative Update
Administrative Update   |   April 2017
The FDA Drug Safety Communication: What Does This Mean About Anesthesia Safety for Mothers and Children?
ASA Monitor 04 2017, Vol.81, 6-8.
ASA Monitor 04 2017, Vol.81, 6-8.
On Wednesday, December 14, the United States Food and Drug Administration (FDA) released a Drug Safety Communication (www.fda.gov/Drugs/DrugSafety/ucm532356.htm) warning that “repeated or lengthy use of general anesthetic or sedation drugs during surgeries or procedures in children younger than 3 years of age or in pregnant women during the final trimester may affect development of children’s brains.” The FDA defined “lengthy” as greater than three hours of exposure.1,*
As a result, the FDA is requiring warnings to be added to the labels of general anesthetics and sedation drugs (Table 1). No specific anesthetic or sedation drug has been shown to be safer than any other, the FDA notes.
First Page Preview
First page PDF preview
First page PDF preview ×
View Large
0 Comments
Submit a Comment
Submit A Comment

Contributors must reveal any conflict of interest. Comments are moderated.

Name
Affiliation & Institution
I have a potential conflict of interest
Comment Title
Comment


This feature is available to Subscribers Only
ASA Member Login or Create an Account ×