2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC107
Submitter : Mr. Frank Maziarski, CRNA, MS Date & Time: 11/01/2005 03:11:09
Organization : Mr. Frank Maziarski, CRNA, MS
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Please do not remove the warnig that Propofol should be Administered Only by Persons Trained in the Administration of General Anestheisa. This warning assures patient safety and prevents incresased morbidity and mortality. Removing this label is especialy dangerous becouse it will allow non anesthesia providers to use Propofol in situations requireing conscious sedation in office, clinic, dental and other venues where emergency help is not available. The net result will be an increase in patient injury and even death. Propofol should only be administered by a CRNA or an anesthesiologist.