2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC53
Submitter : Dr. Robert Gordon Date & Time: 09/19/2005 08:09:00
Organization : Westchester Medical Center, Valhalla, N.Y.
Category : Drug Association
Issue Areas/Comments
Who might "other qualified Medical Professionals" be? I am an anesthesiologist who is frequently involved in these GI cases. The line between sedation and apnea (NO BREATHING) with the use of Propofol is a thin one. Who in the room will attend to the airway when apnea occurs? GI physicians really do not understand what they are asking for. In a hospital setting, they can be bailed out by calling for help; Who will they call in an office-based setting?
If the FDA is interested in standard of care, in health, they will deny the request that Propofol labeling be changed.