2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC88
Submitter : Dr. Brian Cook Date & Time: 09/19/2005 09:09:37
Organization : New York Anesthesia Associates, P.C.
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
The argument against removal of the Propofol Warning is crystal clear! Removal of this warning will lead to patient death. If there are a handful of medical professionals other than anesthesiologists administering propofol, then they are playing with fire. Propofol is the only drug of its kind; one without a reversal agent, and one which leads to unpredictable changes in levels of sedation, changes that are sometimes as dramatic as they are sudden, changes that sometimes require airway management,a skill rarely held by medical professionals other than anesthesiologists. The data supporting the safe administration of propofol by gastroenterologists has absolutely no value. For if an anesthesiologist and a gastroenterologist have safely administered two, three, even ten thousand propofol anesthetics without the need for airway management, they are still not equivalent. Tell me who you, the two, three, or even ten thousand and first patient, would like to have in the procedure room when you suddenly slide down the slippery slope of conscious sedation to respiratory arrest, laryngospasm, hypoxia, and ultimately death. I know who I'm choosing. And if patients were allowed to make an educated choice, I know who they would choose as well. That patient could be me, you, or our loved one someday. In an era where patient safety has been advanced so tremendously, do not create an unfortunate setback by removal of the current propofol warning! This issue could not be more cut and dry. Anyone who argues otherwise is either ignorant or has questionable motives. Remember, the issue is not whether a gastroenterologist, or other non-anesthesia trained medical professional, can or cannot administer propofol safely. The issue is - AND THIS CANNOT BE MISSED - whether or not that medical professional can rescue a patient and secure their airway before it is too late!!! Until there is some data showing that gastroenterologists, ER doctors, etc. are as good at airway management as anesthesiologists, the propofol warning cannot be removed. To do so would be reckless, irresponsible, and WILL result in unneccessary death, period.