2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC157
Submitter : Dr. David Bogdonoff Date & Time: 11/17/2005 01:11:09
Organization : University of Virginia
Category : Health Professional
Issue Areas/Comments
Dear DEA Official,
I believe that it is inappropriate to consider handing over the administration of propofol to health care providers that do not possess skills in airway management. While one may debate whether ICU and Emergency Room physicians that do have airway skills should sedate patients with propofol, there is no room for debate on the issues of others who do not possess airway skills (such as gastroenterologists). As an anesthesiologist who uses propofol on a regular bases, I assure you that patients stop breathing when given too much. There is also a high incidence of undesired hypotension associated with its use. Furthermore, there is a high degree of inter-patient 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 and cardiovascular 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.
David L. Bogdonoff, MD
Associate Professor of Anesthesiology and Surgery
Medical Director, Perioperative Services
University of Virginia Health System