2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC153
Submitter : Dr. Gene Gordon Date & Time: 11/08/2005 08:11:42
Organization : Sylacauga Anesthesia, P.C.
Category : Health Professional
Issue Areas/Comments
I am an anesthesiologist with over 20 years of experience,and have used propofol since it was in clinical trials. It is a wonderful drug for both general anesthesia and deep sedation, but one that can quickly cause problems that non-anesthesia personnel ( including non-anesthesia physicians )are often unable to correct.Propofol can easily cause a patient to slip from moderate or deep sedation to general anesthesia. This can lead to loss of open airway, cessation of breathing,severe drop in blood pressure,marked drop in heart rate,drop in blood oxygen saturation, and other problems. Even though other physicians may have some training or experience in airway maintenance, endotracheal intubation or be ACLS certified, they certainly do not manage such problems with the skill or ease of an anesthesiologist, or even that of an unsupervised CRNA. I began my career with an internal medicine internship in the U.S. Air Force and served 4 years as a general practioner, as well as working as a moonlighting E.R. physician.I was ACLS certified and was considered adept at airway management.However, I later found that my skills were not even close to those of a junior anesthesiology resident.In my hospital and in hospitals, emergency rooms, GI labs, cardiac cath labs and radiology suites across the country, the anesthesiologist is always who they want when things "go south".Opening propofol use to non-anesthesia trained personnel, let alone a physician who is also performing an endoscopic procedure is jeopardizing patient safety. If it's us who they call when they are in trouble, wouldn't it be better for us to be there in the first place and maybe avoid that trouble or handle it as we do every day in our practice? Although I can deliver babies,perform upper GI endoscopies, and do minor surgeries safely, and perhaps do several hundred of each without harm to a patient,I would always be just one complicated patient away from a tragedy. There are physicians better trained to handle these patients and procedures, and they do it every day for a living.Anesthesiologists handle deep sedation, general anesthesia,airway problems,hypotension,cardiac arrhythmias, ventilation problems, and perform endotracheal intubations every day for a living. We do it with an estimated mortality rate of 1:300,000. Why would we consider placing patients at higher risk just for the economic benefit of gastroenterologists? Is the $400 -$600 they receive for a 5 to 15 minute procedure inadequate? Even if the reason is to lower costs of endoscopic procedures for third party payers, since when have we become willing to sacrifice the occasional life to save the $100 to $275 per procedure it costs to have an anesthesia provider there to do what they do best?