2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC123
Submitter : Dr. David Rapkin Date & Time: 11/01/2005 04:11:38
Organization : University Anesthesiologists, Inc
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am the Chairman of Anesthesiology at a University-affiliated hospital in Cleveland, OH. Propofol is a very important anesthetic drug that has significant side effects when used by physicians that are not well-trained in either anesthesia or emergency airway rescue techniques. There is potentially a very small margin of safety between sedation and general anesthesia. It is an unpredictable drug especially when used with other sedatives. The practitioner must be prepared to rescue an airway immediately and skillfully. Unlike other sedatives typically used by gastroenterologists(e.g. versed and demerol), airway obstruction and apnea can occur very quickly with propofol and there are no antidotes. Propofol is a drug which should only be used by practitioners trained in general anesthesia.