2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC151
Submitter : Dr. Douglas Redfield Date & Time: 11/01/2005 04:11:57
Organization : CHESHIRE MEDICAL CENTER
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I reccomend that that the proposal be rejected. Use of Propofol is inherenly dangerous causing rapid loss of conciousness, apnea and loss of airway protective mechanisms. Unlike other medications use in the Gastenterology suite and in other areas Propofol does not have a reversing agent. (ie, Narcotic or benzodiazepams. Use of propofol by practitioners not facile in airway management inappropriately puts patients at significant risk.
Thank you for your consideration of this matter.
Douglas A. Redfield MD
580 Court Street
Keene, NH 03431
603 355 8854