RM Global Health

The ASA submitted formal comments and testified before the Food and Drug Administration’s (FDA) Anesthetic and Life Support Drugs Advisory Committee (ALSDAC) requesting that the labeling for fospropofol disodium injection 35 mg/ml (fospropofol) include a similar warning to that which is included on the label for propofol.  Because fospropofol is a pro-drug of propofol and is metabolized in the blood stream into propofol, for patient safety reasons the ASA believes that the drug should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Dr. Thomas Henthorn, Professor and Chair of the Department of Anesthesiology at the University of Colorado, provided oral comments to the committee on behalf of the ASA.