2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC111
Submitter : Dr. Craig Brener Date & Time: 11/01/2005 03:11:56
Organization : Dr. Craig Brener
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Removing the current warning would be detremental to patients. Having administered propofol for colonoscopy, EGD and ERCP in endoscopy units about 1,000 times, I have had to use my resuscitative stills as an anesthesiologist on multiple occasionals. Despite cautious administration of propofol, certain patients will obstruct their airway requiring ventilatory support, or become hypotensive requiring pharmacotherapy for hemodynamic support. It would be unwise to let the responsibility of ventilatory and hemodynamic management fall on gastroenterologists and endoscopy nurses.