2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC145
Submitter : Dr. Jeffrey Queen Date & Time: 11/01/2005 04:11:04
Organization : Children's Anesthesiologists, PC
Category : Health Professional
Issue Areas/Comments
On behalf of my organization, I urge you NOT to change the labelling of propofol so that it can be used by non-anesthesia trained personnel. This will set back patient safety decades. As anesthesiologists, we have promoted patient safety through new monitors, drug administration, etc. In a time when the public eye is acutely focused on the medical profession regarding safety, changing the labelling of propofol would serve only to promote further public mistrust. Propofol is an anesthetic, not an analgesic or hypnotic. As such, it should be treated appropriately. The studies promoted by the gastroenterologists stating that the use of propofol by non-anesthesia personnel simply do not pass our test of safety. The Institute of Medicine even stated that the practice of anesthesiology came the closest to being a six sigma field of medicine. I am proud of this fact. I do not want to see the public placed in potential dire straits as a result. Over fifteen years ago, midazolam was considered safe. It took a number of catastrophes in the GI suites to bring to the forefront the potential dangers of this drug. Please do not let this happen with propofol. I thank you for your time and duly wish you to consider this plea.