2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC132
Submitter : Mr. Oscar Penate Date & Time: 11/01/2005 04:11:59
Organization : UW School of Medicine
Category : Health Professional
Issue Areas/Comments
The current package insert provides: "For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN Injectable Emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.? This warning is still critical for patient safety. It is consistent with ASA's Statement on the Safe Use of Propofol.

Even if the clinician administering propofol intends to produce a state of deep sedation, general anesthesia is often the result. Patients vary, with little predictability, in their reactions to propofol.

Physicians administering propofol must be thoroughly trained to identify and treat immediately patients who lose an airway or who experience cardiovascular difficulties, as well as in the pharmacodynamics of propofol.

Because of the potential for life-threatening emergencies, the physician who is administering propofol must not simultaneously be performing the endoscopy or any other procedure-- there must be a dedicated, trained, independent clinician observing the patient continuously, ideally an anesthesiologist.

It is evident from the ACG's claims, that their only motivation for removing the warning label from propofol, stems from a desire to increase their economic revenue, selfishly ignoring the risks that such actions may bring to the patient should an unexpected event occur.

Therefore, I ask that you deny the ACG's petition to remove the warning label from Diprivan and continue to advocate for the most important reason your agency was created for--patient safety.