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ASA Files Comments on FDA Propofol Petition

ASA's letter urges FDA to retain the warning label limiting the use of propofol to clinicians trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.

SUBMITTING COMMENTS TO FDA ON PROPOFOL LABELING

The FDA will continue to accept comments until December 27, 2005. You may submit comments either by mail to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Be sure to include the Docket Number 2005P-0267

or submit electronically on the FDA's website.

Key points you might make include (illustrate with examples from your own experience, if possible):

  • 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 -- there must be a dedicated, trained, independent clinician observing the patient continuously.