2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC115
Submitter : Mr. Joe Lesser CRNA, ARNP, M Date & Time: 11/01/2005 04:11:50
Organization : Kentucky Association of Nurse Anesthetists
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Due to the fine line between sedation and general anesthesia when propofol is used, with resultant loss of airway reflexes, propofol should only be used by anesthesia professionals. This insures that someone who can rescue the patient's airway is administering the drug. A patient can present with a difficult airway that would not be recognised by non-anesthesia personnel, and die when the unskilled personnel attempt to administer propofol. Non-anesthesia personnel are attempting to utilize propofol without an anesthesia professional in order to save costs, but are doing so at the risk of ptient lives. The FDA label for propofol needs to limit the use of propofol to anesthesia professionals only.