2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC130
Submitter : Dr. Kevin Pace Date & Time: 11/01/2005 04:11:27
Organization : Dr. Kevin Pace
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
As a practicing anesthesiologist, I am called more frequently than one would hope to assist with lost airways during oversedation in the GI lab. This is when versed/demerol are being used; drugs which are easily reversible. It is because of this lack of experience with airway management that I cannot agree with the useage of propofol by anybody other than anesthesia personel, unless the patient is already intubated. There is no reversal agent, and it is a drug who's titration varies tremendously among individual patients. I fear increase in lost airway/oversedation issues will increase dramatically, and the public safety will be jeopardized. Propofol is an anesthetic agent. Please acknowledge the expertise of my field by not allowing this label change to occur.