2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC181
Submitter : Dr. Mark Schneider Date & Time: 12/07/2005 01:12:27
Organization : American University of the Caribbean School of Med
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Professional training in the administration of anesthetics, sedatives, and paralytics is and should remain in the hands of board certified medical specialists, i.e. Anesthesiologists. As is true with most practices within medicine, anyone can be "trained" to perform a procedure or administer a drug. The problem lies within the ramifications and complications that are inevitable in our profession. Anaphylaxis or any host of complications are inherent within administration or performing medical procedures. Who do you want to administer propofol to your child when there is a 3-5% chance that they may sieze or go into respiratory failure. I would strongly urge you to truly evaluate the potential catastrophic events that can and will occur and who is qualified to adequately manage these inevitable complications.