2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC74
Submitter : Dr. Leo Stemp Date & Time: 09/19/2005 09:09:59
Organization : Western Mass Critical Care, PC
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am an anesthesiologist who provides sedation in many gastroenterology endoscopy suites. Fairly heavy sedation is often necessary to complete endoscopic procedures. Although such can be accomplished with midazolam/fentanyl, or other sedative/opiate agents, propofol is certainly THE ideal agent to accomplish this with. However, the vast majority of gastroenterologists, and virtually all the endoscopy nurses (non-anesthesia trained) have no clue about how to manage patients under deep sedation, which by definition causes airway and respiratory compromise. The notion of non-anesthesia trained individuals using propofol is simply laughable, and would predictably lead to tragedies even greater than those that occurred with the original introduction of midazolam.

Attached is the policy I wrote in regards to the use of propofol for sedation.

I would appreciate your taking this into account during your deliberations.

Sincerely,

Leo Stemp

SEE ATTACHMENT
2005P-0267-EC74-Attach-1.DOC