2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC103
Submitter : Ms. Kristan Marter Date & Time: 10/13/2005 11:10:31
Organization : Ms. Kristan Marter
Category : Health Professional
Issue Areas/Comments
I am concerned about patient safety. Propofol does not have a reversing agent and just a little too much can cause a patient to slip into a deep sedation that can be life threatening. If you don't have an individual that is trained to administer anesthesia, as well as rescue a patient from deep sedation, you run the risk of a severly injured patient (hypoxia leading to brain dusfunction) or a dead patient! The FDA included the warning in their package insert for a reason! Why would you want to take the risk!!!