2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC108
Submitter : Dr. William Simpson Date & Time: 11/01/2005 03:11:22
Organization : Dr. William Simpson
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
As a practicing gastroenterologist who uses propofol for endoscopic sedation on a daily basis, I do not feel that modification of this labeling is in the best interest of my patients. This is the most ideal drug for endoscopy currently available, but it is a potent hypnotic that must be administered appropriately. The use by anesthesia providers allows for both optimal dosing and the proper management of the patient's airway. In my opinion, the administration by anesthesia providers offers the most clinically effective and safest sedation for GI endoscopy. Administration by the endoscopist (nurse supervised by the endoscopist), in my opinion, requires a high level of attention from the endoscopist to hemodynamic and airway management. Why compromise either the endoscopic procedure or the safe sedation of the patient when we do not need to? In this instance, the requied availability of an anesthesia provider improves patient comfort and safety at an acceptable financial cost.