ASA Comments at FDA Hearing on Fospropofol
Chicago —
(May 8, 2008)
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.
THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS
Anesthesiologists: Physicians providing the lifeline of modern medicine. Founded in 1905, the American Society of Anesthesiologists is an educational, research and scientific association with 46,000 members organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient.
For more information on the field of anesthesiology, visit the American Society of Anesthesiologists Web site at www.asahq.org. For patient information, visit LifeLineToModernMedicine.com
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