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U.S. Department of Health and Human Services


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Audience: Pediatricians and Pediatric ICU healthcare professionals

The FDA has determined that there may be important safety concerns when propofol, marketed by AstraZeneca as DIPRIVAN (propofol) Injectable Emulsion, is used for sedation in the Intensive Care Unit (ICU) in pediatric patients. Healthcare professionals are reminded that propofol is not approved in the U.S. for sedation in pediatric ICU patients.

[April 25, 2001 - Letter - AstraZeneca Pharmaceuticals]