2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC95
Submitter : Dr. Beemeth Robles Date & Time: 09/21/2005 06:09:00
Organization : Metro Anesthesia Consultants
Category : Health Professional
Issue Areas/Comments
Dear FDA Staff:
I do not need to tell you that anesthesiologists are experts in anesthesia related pharmacology, physiology, the management of pathophysiology in light of anesthetic exposure and of course, they are experts in airway management. We do what we do effortlessly and give the impression that what we do is straight forward and easily mimic able. From the outside, it would appear that we do what we do without any consideration but that is only due to the fact that we are trained experts. Propofol is an anesthetic induction drug and was designed for that purpose. In addition, with time and experience we have expanded the indications of Propofol to the point that now those with no appreciation for the risks of Propofol, want to have a free for all so that they can experiment with the public. I need not remind you that a couple of decades ago a drug by the name of Midazolam was brought to the market and then later its safety was questioned. A drug that I have used for almost as long as it has been available without any complications related to its use, was nearly pulled from the market because patients were dying due to its misuse. What is more crucial is that Midazolam and Propofol are very different in their ability to cause apnea. What will one do when a patient given propofol goes apneic? For the anesthesiologist its no problem, afterall we use propofol in amounts to do just that, cause apnea, followed by airway manipulation and management. This is the very reason we give the impression that Propofol is safe and easy to use, but those around us forget that it is safe because we are trained professionals.

Furthermore, if the reason we choose to loosen restrictions on the use of Propofol is due to the costs of healthcare, should we really let those with little or no experience using Propofol experiment with patients? How much will we save by allowing those who lack the skills to manage a drug which has been shown to be safe in trained hands, but is now placed in inexperienced hands and made potentially lethal? Will the dollars we save by allowing the wrong people to administer Propofol provide the justification for the deaths that will follow? Let us remember that the company who manufactured Propofol was required to study the drug extensively before it was released to the public. The research was vast and the end result recommendation of that research was that Propofol should be used by individuals trained in anesthesia care. This very comment should be sufficient to continue keeping the public safe and free of experimentation. If my letter sounds alarmist, it is because I would hope that you will appreciate the potential risk that exists with this drug. There is no dose, short of an inadequate sedation dose that is guaranteed not to cause apnea and there are patients that require far larger doses than those individuals who lack the experience with this drug, will have to use. I just don?t understand why anyone would consider allowing individuals that have not been trained in anesthesia to do something that is akin to experimenting with people. It is my hope that this letter will be followed by many, many more so that we can impress upon you that the decision to loosen the restrictions on the use of Propofol is an extremely shortsighted consideration.

Should you wish to explore these comments further, I can be reached at 480-239-4002 or 77 E. Columbus Ave, Ste 201, Phoenix, AZ 85012.


Beemeth T. Robles, MD