2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC67
Submitter : Dr. James York Date & Time: 09/19/2005 09:09:35
Organization : Anesthesia Consultants Medical Group
Category : Health Professional
Issue Areas/Comments
Propofol is a potent sedative, hypnotic, anesthetic agent. Thiopental and other potent barbituates, Brevital, Ketamine, and Etomidate are likewise potent sedative, hypnotic, dissociative, and anesthetics. As a physician who routinely administers these drugs, it would be foolhardy for individuals to administer these drugs without advanced training in airway management, intubation, pharmacology of the agent, and a complete understanding of how these drugs interact with other medications frequently used in outpatient settings like Versed, Demerol, Morphine, or whatever the whim of the practitioner might be. When disaster happens to a patient, for the first time, I will be glad to serve as an expert witness for something that should not occur. I cannot imagine attempting to do a procedure like a bronchoscopy, endoscopy, or colonoscopy safely while hoping my nurse knows what they are doing with the airway. If practitioners wish to be trained in the safe and correct use of these medications that can very easily kill, encourage them to complete a residency in anesthesiology where they can demonstrate their knowledge and abilities before winging it. It has been a difficult road to become an anesthesiologist. Airway management under Propofol administration is not 'conscious sedation' but rather unconscious, or a general anesthetic. Patients cannot respond to verbal stimuli under Propofol at the levels required for these procedures. Perhaps, we should just hand out anesthesia machines with vaporizers, or why stop at Propofol, why not any induction agent, ultimately each has a similar pharmacologic effect- unconsciousness, loss of airway reflexes, cardiovascular depression, and respiratory depression are the tip of the iceberg. Taking the argument to the next level, why can't a surgeon administer anesthesia while doing his procedure? I'm sorry for the diatribe but common sense and safety must be higher goods for society than convenience for the operating endoscopist.