2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC18
Submitter : Dr. Scott Robinson Date & Time: 08/25/2005 11:08:29
Organization : Anesthesiology Consultants of Marin
Category : Health Professional
Issue Areas/Comments
The current labelling on propofol was almost certainly created with the evidence that administration in non-intubated patients causes hemodynamic instability in a certain percentage of patients, but also airway obstruction in many more. Training in anesthesia administration allows these two drug effects to be safely managed even when they occur together. Lack of such training would obviously result in an inferior standard of care.

My recommendation would be to keep the present labelling, becasue with trained anesthesiology practitioners in attendance, patients receive a level of care exactly as they would in the operating room.