2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC142
Submitter : Dr. Paul Samuelson Date & Time: 11/01/2005 04:11:43
Organization : UAB Medical Center
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I have been practicing clinical anesthesiology since 1972. My practice is in an academic medical center and mainly for cardiothoracic surgical procedures and pediatric cardiac catheterization. Most of our patients come from or go to intensive care units. I have extensive experience with propofol as a sedative and as a component of general anesthesia. I am continuosly impressed by the widely variable clinical sensitivity to propofol dosage and how this interacts with concomitant medications. It is scary how quickly a patient can become depressed by minimal doses of propofol. It is paramount that these variations be anticipated, recognized, and rapidly treated. This is the area of expertise of anesthesiologists (by training and their medical practice) and I feel strongly that propofol administration should be done only by those trained in the induction and maintenance of general anesthesia.