2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC156
Submitter : Dr. George Politis Date & Time: 11/17/2005 01:11:59
Organization : University of Virginia Health System
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Dear DEA official,
I believe that it is outrageous that anyone would consider handing over the administration of propofol to a health care provider with no skills in airway management. While the debate has raged for several years regarding whether ICU and Emergency Room physicians, who do have airway skills, should sedate patients with propofol, I have not been aware that others who possess no airway skills (such as gastroenterologists) also want to be able to use it. As an anesthesiologist, who uses propofol on a regular bases, I assure you that patients stop breathing when given too much. There is a high variability in the amount that is required, and it is therefore easy to give too much. The key is to know how to observe for respiratory problems, intervene quickly and effectively. Anesthetic mishaps that result in serious morbidity and mortality are rare. Therefore, to show that a particular practice is dangerous may take thousands of cases, or hundred thousands of cases. There is no medical literature with sufficient numbers to document that propofol would be safe in the hands of gastroenterologists or their nurses. Finally, anesthesiologists have no financial interest in this issue. Passing this docket would not represent revenue loss for the anesthesiologist because we almost never have involvement in these cases that are usually performed with benzodiazepines and narcotics, without an anesthesiologist present. I strongly believe that the current practice is much safer than releasing an intravenous general anesthetic for use by individuals without training in its use and without training in management of airways.
Sincerely,
George D. Politis, MD, MPH
Associate Professor of Anesthesiology and Pediatrics