2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC19
Submitter : Dr. David Mackey Date & Time: 08/25/2005 11:08:00
Organization : University of Florida
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
The initiative to remove the above warning from the propofol label is ill-advised. There have been several recent propofol sedation deaths in Florida involving administration by non-anesthesiologists, and such a label change will only accelerate the incidence of such tragic events. The label must remain unchanged.