2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC137
Submitter : Dr. Roger Mattison Date & Time: 11/01/2005 04:11:45
Organization : Dr. Roger Mattison
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
The current labeling for Propofol accurately delineates the safety precautions for the use of this drug and should not be modified. As an anesthesiologist working in and Ambulatory Surgery Center immediately adjacent to an invasive endoscopy suite, I am called on a regular basis to assist with airway rescue of patients who are over sedated with midazolam and fentanyl. It is clear to me that, under the direction on the endoscopist, the nurse administering sedation for some cases exceeds the safety margains for conventional sedation. There is a high motivation on the part of the endoscopy team to complete the procedure leading to injudicious use of sedation drugs. Adding propofol to the agents available for procedural sedation where no one is trained in administering general anesthesia is going to lead to a increase in airway emergencies and a considerable risk of patient deaths. Propofol is an intravenous anesthetic with properties and pharmacologic behaviors unlike any sedative drug. The label warning acknowledges the differences in this drug and should not be modified. In light of my experience with endoscopy sedation I wonder if the FDA should require all procedural sedation to be outsourced to individuals with anesthesia supervision.