2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC171
Submitter : Dr. Scott Schartel Date & Time: 11/17/2005 01:11:10
Organization : Dr. Scott Schartel
Category : Health Professional
Issue Areas/Comments
I write to urge that the package labeling for propofol NOT be changed. The warning that propofol, when used for sedation or general anesthesia, should be administered by persons trained in the administration of general anesthesia and who are NOT involved in the surgical or diagnostic procedure is appropriate and should remain. This injunction is an important patient safety warning.

While propofol is an excellent medication, patients' responses to propofol are quite variable: a dose that will not cause sedation in one patient may cause apnea in another patient. During propofol sedation it is common for patients to enter a deeper level of sedation than intended; apnea is not rare.

Deep sedation and general anesthesia, which may be hard to distinguish from each other, are associated with the potential for airway compromise and/or apnea. The treatment of airway obstruction and/or apnea requires early recognition of the problem and advanced airway skills for its management. ACLS or PALS training does not ensure proficiency in airway management. Unless the person administering the sedation is able to manage the airway obstruction and/or apnea quickly and effectively, the patient will suffer harm. Good and safe patient care requires the early recognition of the problem. The person administering and monitoring the sedation must not only be able to manage the acute airway problem, but must also be able to return the patient to the desired level of sedation, if a deeper plane of sedation is achieved than was planned. It is inconsistent with safe patient care for the person who is administering propofol sedation to be participating in the surgical or diagnostic procedure. The person administering sedation with propofol must devote her/his undivided attention to monitoring the patient.

Propofol does not have an antagonist, unlike narcotics and benzodizapenes, emphasizing the importance of propofol being administered by practioners with advanced skills.

The American Society of Anesthesiologists position statement on the Safe Use of Propofol emphasizes the points I have made above. The purpose of that statement, and of my comments, is to urge you to continue to support safe patient care by rejecting the petition to change the labeling of propofol.

Thank you for your consideration of these comments.

Scott A. Schartel, DO
Professor & Associate Chair for Education
Department of Anesthesiology
Temple University
Philadelphia, PA