2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC35
Submitter : Dr. ROBERT STEVENSON Date & Time: 08/29/2005 12:08:03
Organization : Magnolia Anesthesia, LLP
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
The line between sedation & general anesthesia (with airway loss) varies ten-fold between patients. The change can occur in 20 seconds. Anyone who cannot manage an airway skillfully & rapidly haas no business with propofol administration. What is an acceptable death-rate for GI endoscopy, 1 in 5000 or 1 in 250,000?